US FDA grants orphan drug status to Insys Therapeutics' pharmaceutical cannabidiol to treat brain cancer...

Specialty pharmaceutical company Insys Therapeutics, Inc. has received the US Food and Drug Administration's orphan drug designation for its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumour in humans.

"We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients," said Michael L. Babich, president and chief executive officer.

In addition to receiving orphan drug designation, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI's patent rights related to the usage of cannabinoids for the treatment of GBM.

In concert with the aforementioned exclusive licensing agreement, Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment. "Based on previous research conducted with CBD to treat brain tumours, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans," said Dr. McAllister.

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility, located in Round Rock, Texas. The company recently submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient and believes that it is the only US-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

Insys was previously granted ODD to its pharmaceutical CBD for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids. Insys intends to pursue orphan drug designation for other indications that may qualify.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a seven-year period of US marketing exclusivity, as well as certain financial incentives that can help support its development.

Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumours and one of the most aggressive forms of cancer. The aggressive behavior of GBM is secondary to its high invasiveness and proliferation rate as well as to its high resistance to standard chemotherapy and radiotherapy. Current therapeutic strategies for the treatment of GBM fail to demonstrate adequate efficacy and/or are generally palliative. Despite decades of research into its treatment, prognosis remains poor, with median overall survival of 12 to 14 months. Therefore it is important to identify new treatment modalities to improve therapeutic efficacy and enhance GBM chemosensitivity.

Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients.

USFDA: New and Generic Drug Approvals: 27 AUG 2014

New and Generic Drug Approvals

August 27, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ClonazepamclonazepamTablet;OralSun Pharm Inds IncApproval
Elelysotaliglucerase alfaPowder;Iv (Infusion)PfizerEfficacy Supplement with Clinical Data to Support
Elelysotaliglucerase alfaPowder;Iv (Infusion)PfizerLabeling Revision
Ellaulipristal acetateTablet;OralLab Hra PharmaLabeling Revision
Megestrol Acetatemegestrol acetateSuspension;OralTwi Pharms IncApproval
Metoprolol Tartratemetoprolol tartrateInjectable;InjectionGland Pharma LtdApproval
Nephramine 5.4%amino acidsInjectable;InjectionB BraunManufacturing Change or Addition
Olopatadine Hydrochlorideolopatadine hydrochlorideSolution;OphthalmicWatson Labs IncTentative Approval
Phoslyracalcium acetateSolution;OralFresenius MedclManufacturing Change or Addition
Vimovoesomeprazole magnesium; naproxenTablet, Delayed Release;OralHorizon PharmaManufacturing Change or Addition
Xopenex Hfalevalbuterol tartrateAerosol, Metered;InhalationSunovionManufacturing Change or Addition

USFDA Manual of Policies and Procedures: Communicating Drug Approval Information

USFDA: CDER KEY OFFICIALS as on 29 AUG 2014

50 States, One Goal: Working Together to Keep Our Food Safe ...!!!

By: Melinda K. Plaisier and Michael R. Taylor
Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.
Melinda K. Plaisier
The August 12 conference in St. Louis of the Partnership for Food Protection (PFP) was truly a meeting of the minds. This 50-state workshop drew food and feed safety experts from federal, state, local, tribal and territorial government agencies. These organizations make up the PFP. Our shared goal? To continue working towards a food safety system in our country that makes our food as safe as possible.
Partnerships have become increasingly important in our efforts. Simply put, we can’t do it alone. The scope of the public health mission is too vast. We need to take advantage of the unique contributions state and local partners can make through their food safety commitment, knowledge of local conditions and practices, and local presence to deliver training, technical assistance and compliance oversight. Together, we can ensure an effective public health safety net.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.
Michael R. Taylor
But building the kind of partnership we envision is an extraordinarily complex task. There are 3,000 food safety agencies in this country at the federal, state and local level. The challenge we face is this: How do we make PFP a reality that will work for decades to come? Working together to corral the complexities of our global food supply is critically important to our success and represents a significant shift in the way we work.
And creating that new reality is what our recent meeting was all about.
FDA itself is in a time of transition through Commissioner Hamburg’s initiative of program alignment. The agency is working to better align internal operations, increasing specialization among inspectors, compliance officers, laboratory staff and others to give them increased technical knowledge in a specific commodity area, and partnering them with subject matter experts in FDA’s centers. Ultimately, this will streamline decision-making and provide real-time technical and policy support for frontline staff.
This effort will better position FDA to meet the challenges we face, including the continued evolution of science and technology, the reality of globalization, and implementing the rules we are working to finalize that will help make the FDA Food Safety Modernization Act (FSMA) a reality—each rule,  in its own way, transformative.
Speaking with one voice as an agency and acting in unison across internal boundaries will enable FDA to better support our state partners as we all work to use innovative tools, training and approaches.
Our collaborations with the Association of Food and Drug Officials, the National Association of State Departments of Agriculture, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials, the National Environmental Health Association, and the Association of Public Health Laboratories—just to name a few—are equally valuable in this cause.
We are well on our way toward making our partnership through PFP a foundation of the modern infrastructure we are building to protect public health. Our partners are engaged, and FDA is all in. And now we are truly beginning to see some of the fruits of our labor. Until we meet again, our work continues.
Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.
- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/08/50-states-one-goal-working-together-to-keep-our-food-safe/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.pqRXgDSD.dpuf

USFDA: New and Generic Drug Approvals: 26 AUG 2014

New and Generic Drug Approvals

August 26, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
DostinexcabergolineTablet;OralPharmacia and UpjohnLabeling Revision
EntecavirentecavirTablet;OralTeva Pharms UsaApproval
FurosemidefurosemideInjectable;InjectionEmcure Pharms LtdApproval
Memantine Hydrochloridememantine hydrochlorideTablet;OralMacleods Pharms LtdTentative Approval
NevirapinenevirapineTablet, Extended Release;OralMylan Labs LtdTentative Approval
Primaxincilastatin sodium; imipenemInjectable;InjectionMerckManufacturing Change or Addition
Promactaeltrombopag olamineTablet;OralGlaxosmithklineEfficacy Supplement with Clinical Data to Support
TelmisartantelmisartanTablet;OralZydus Pharms Usa IncApproval
Telmisartan and Amlodipinetelmisartan;amlodipineTablet;OralMylan Pharms IncApproval
XalkoricrizotinibCapsule;OralPf Prism CvManufacturing Change or Addition

MHRA: Medical Device Alert

This medical device alert is being issued due to the risk of some of the devices within the highlighted product codes having small cracks or holes. This could compromise the sterile field.

Medical Device Alert: Basin/bowl liner or equipment cover (drape) manufactured by Microtek Medical (MDA/2014/034)

USFDA: Warning Letter - APIs like chlorzoxazone, diclofenac, indomethacin, ibuprofen and naproxen in Dietary Supplements Products !!!

HUMAN SCIENCE FOUNDATION 8/18/14
  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415 
SIGNATURE REQUIRED

 Human Science Foundation
13722 Harvard Pl
Gardena, CA 90249-2527
  
• "Better Performance ... Better Flexibility ... Better Mobility"
• "With Pro ArthMax, they could work better, move better, and feel better."

• "Super Arthgold may improve the blood circulation, which can help relieve soreness caused by lactic acid build-up in the muscle tissues. Better blood flow can also contribute to increased range of motion in the joints, which may help arthritis and joint pain."


/S/
Alonza E. Cruse, Director
Los Angeles District
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
WARNING LETTER
VIA UNITED PARCEL SERVICE
W/L#33-14
August 18, 2014
Mr. Sean S. Lee, President/Owner
Dear Mr. Lee:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 13722 Harvard Pl, Gardena, CA 90249 from January 8 through 16, 2014. During the inspection, the FDA investigator collected samples of "Pro ArthMax" and "Super Arthgold" products. Based on our review, your "Pro ArthMax" and "Super Arthgold" products are unapproved drugs in violation of section 505(a) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") [21 U.S.C. § 355(a)] and are misbranded in violation of sections 502 and 503(b)(1)(A) [21 U.S.C. §§ 352 and 353(b)(l)(A)] of the FD&C Act. The introduction or delivery for introduction into interstate commerce of these products would violate sections 301(d) and 301(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 331(a)].
FDA laboratory analyses confirmed the following undeclared ingredients in your distributed products:
• "Pro ArthMax" - Chlorzoxazone, Diclofenac, Indomethacin, Ibuprofen, Naproxen, and Nefopam.
• "Super Arthgold" - Chlorzoxazone, Diclofenac, and Indomethacin.
Chlorzoxazone is the active pharmaceutical ingredient (API) in the FDA-approved drug Parafon Forte® DSC, approved on August 15, 1958, and is a prescription drug used to relieve musculoskeletal pain. Diclofenac, indomethacin, ibuprofen, and naproxen are non-steroidal anti-inflammatory drugs (NSAIDs) and APIs found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions, including some arthritic conditions.1 Nefopam is a non-opioid analgesic and is not approved for use in the United States.
Your firm's "Pro ArthMax" and "Super Arthgold" products are labeled as dietary supplements. However, due to the presence of the aforementioned APIs that are in FDA-approved drugs, they cannot be dietary supplements under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)], because a dietary supplement cannot contain an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food prior to FDA approval of the article in a new drug. Given that neither chlorzoxazone, diclofenac, indomethacin, ibuprofen, nor naproxen were marketed as dietary supplements or as foods before FDA's approval of Parafon Forte® DSC, Voltaren®, Indocin®, Motrin®, and Naprosyn®, your "Pro ArthMax" and "Super Arthgold" products are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the FD&C Act.
Your products "Pro ArthMax" and "Super Arthgold" are drugs, as defined by section 201 (g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because they are intended to diagnose, mitigate, prevent, treat, or cure disease conditions and/or affect the structure or function of the body. The "intended use" refers to the objective intent of the persons legally responsible for the labeling of drugs and the intent may be shown by the circumstances surrounding the distribution of the article [21 CPR § 201.128]. The intended use of a product may be established through, for example, product labels and labeling (including the name of a product), advertising materials (e.g., catalogs, brochures), or other circumstances surrounding the marketing and distribution of the product.
Claims documenting the intended use of your products include, but are not limited to, the following:
"Pro ArthMax"
• "Promotes healthy joints & cartilage"
"Super Arthgold"
• "Super Arthgold is an 'All-Natural Source Formula' that has been known to help with arthritis, joint, and muscle-related aches and pains."
Moreover, "Pro ArthMax" and "Super Arthgold" are new drugs, as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because the products are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your distribution of "Pro ArthMax" and "Super Arthgold" without approved applications violates these provisions of the FD&C Act.
Furthermore, "Pro ArthMax" and "Super Arthgold" are "prescription drugs" as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or other potentiality for harmful effect, or the methods of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. For example, chlorzoxazone, the muscle relaxant found in both your products, which has been approved for marketing by FDA, is limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug.
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write "adequate directions for use" for prescription drugs. As such, the labeling of "Pro ArthMax" and "Super Arthgold" fails to bear adequate directions for their intended use. They are not exempt from the requirement that their labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved applications are in effect. For these reasons, "Pro ArthMax" and "Super Arthgold" are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
Additionally, under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article's labeling or advertising "is misleading, there shall be taken into account ... not only representations made or suggested ... but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ... ". The label of "Pro ArthMax" does not declare that it contains chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam. Similarly, the label of "Super Arthgold" does not declare that it contains chlorzoxazone, diclofenac, and indomethacin. The undeclared drug ingredients found in these products may pose serious health risks because consumers with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, the NSAIDs (i.e., diclofenac, indomethacin, ibuprofen, and naproxen) found in your products could lead to serious gastrointestional (GI) adverse events such as bleeding, ulceration, and fatal perforation of the stomach and intestines. Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly by taking your products. Your products "Pro ArthMax" and "Super Arthgold" are misbranded under section 502(a) of the FD&C Act, because their labeling fails to reveal facts material with respect to consequences that may result from the use of these products. Your failure to disclose the presence of chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam also renders your products' labeling false and misleading under section 502(a) of the FD&C Act.
The undeclared drug ingredients in your products "Pro ArthMax" and "Super Arthgold," cause your products to also be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because their labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with these products, particularly since someone who takes them would be unaware of the presence of chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and/or nefopam found in these above-mentioned products.
The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
The above is not intended to be an all-inclusive list of violations in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. In addition to the cited violations mentioned above, you have not provided a response to the Inspectional Observations (Form FDA 483) issued to you at the conclusion of the inspection. The observations noted in the Form FDA 483 reviews serious good manufacturing practice (GMP) deficiencies at your facility. It is your responsibility to assure your firm complies with all requirements of the federal law and FDA regulations.
FDA acknowledges that you initiated a voluntary nationwide recall of"Pro ArthMax" (all lots) on January 13, 2014. It is your responsibility to make certain that you do not market or distribute any product with potentially harmful and undeclared ingredient(s).
You should take prompt action to correct all violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your firm's response should be sent to: Acting Director, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612-2506. If you have any questions about the content of this letter, please contact: Dr. Raymond W. Brullo at (949) 608-2918.
Sincerely,

cc:
_____________________________________________________ 
1 Diclofenac is the API in the FDA-approved drug Voltaren®, approved on July 28, 1988; indomethacin is the API in the FDA-approved drug Indocin®, approved on June 10, 1965; ibuprofen is the API in the FDA-approved drug Motrin®,approved on September 19, 1974; and naproxen is the API in the FDA-approved drug Naprosyn®, approved on March 11, 1976.

USFDA Medical Device Class I Recall Alert: DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery...

Recall Class: Class I

Date Recall Initiated: April 16, 2014
Product: The DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate.
Manufacturing Dates: April 20, 2009 through April 15, 2011
Distribution Dates: November 3, 2009 to April 14, 2014
See the Recall Notice or the Firm Customer Notice for a complete listing of affected products with part and lot numbers.
Use: The DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).
Recalling Firm: 
Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
Reason for Recall: DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery.
  • Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.
  • Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
  • In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.
There have been 15 reports of injury associated with the use of this device.
Public Contact: Customers who have questions about this recall may contact DePuy Synthes Customer Support at 1-800- 479-6328, Monday – Friday, 9:00 a.m. to 8:00 p.m. Eastern Time or the sales consultant.
FDA District: Philadelphia District Office
More Information about this Recall: 
On April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers. The notice identified the problem, affected products and tells customer to:
  • Review their inventory and remove affected lots from stock.
  • Call DePuy Synthes at 1-800-479-6329 for a return authorization number
  • Complete and return the verification in the letter included with the notice.

USFDA: New and Generic Drug Approvals: 25 AUG 2014

New and Generic Drug Approvals


August 25, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BacitracinbacitracinInjectable;InjectionXellia Pharms ApsApproval
Buspirone Hydrochloridebuspirone hydrochlorideTablet;OralStrides Arcolab LtdApproval
DiabetaglyburideTablet;OralSanofi Aventis UsManufacturing Change or Addition
FaslodexfulvestrantInjectable;IntramuscularAstrazenecaManufacturing Change or Addition
Invega Sustennapaliperidone palmitateSuspension, Extended Release;IntramuscularJanssen PharmsManufacturing Change or Addition
Kabiven and Perikabivenamino acids;electrolytes;dextrose;lipidInjectable;InjectionFresenius KabiApproval
Membranebluetrypan blueSolution;OphthalmicDorcManufacturing Change or Addition
Oxacillin Sodiumoxacillin sodiumInjectable;InjectionAgila SpecltsApproval
Tafinlardabrafenib mesylateCapsule;OralGlaxosmithklineManufacturing Change or Addition
TricorfenofibrateTablet;OralAbbvieManufacturing Change or Addition
Visionbluetrypan blueSolution;OphthalmicDorcManufacturing Change or Addition

USFDA issued Manual of Policies and Procedures on NDAs and BLAs: Communication to Applicants of Planned Review Timelines..

USFDA issued MAPP on NDAs and BLAs: Communication to Applicants of Planned Review Timelines.

This MAPP established procedures for informing applicants of the planned review timeline, including the goal dates for discussion of labeling and post-marketing authorization requirements (PMRs) and commitments (PMCs), for original new drug applications (NDAs), Biologic Licensing Application (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER).

Click the link for detailed manual of policies and procedures. 

USFDA: New and Generic Drug Approvals: 22 AUG 2014

New and Generic Drug Approvals

August 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmpyradalfampridineTablet, Extended Release;OralAcordaManufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.11% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.33% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 10% In Plastic ContainerdextroseInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% In Half-Strength Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 2.5% In Plastic ContainerdextroseInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 4% In Modified Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% In Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% In Plastic ContainerdextroseInjectable;InjectionB BraunManufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 7.7% In Plastic ContainerdextroseInjectable;InjectionB BraunManufacturing Change or Addition
Fexofenadine Hydrochloridefexofenadine hydrochlorideTablet;OralAurolife Pharma LlcTentative Approval
GilenyafingolimodCapsule;OralNovartisManufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionB BraunManufacturing Change or Addition
Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Containerlidocaine hydrochlorideInjectable;InjectionB BraunManufacturing Change or Addition
Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Containerlidocaine hydrochlorideInjectable;InjectionB BraunManufacturing Change or Addition
Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Containerlidocaine hydrochlorideInjectable;InjectionB BraunManufacturing Change or Addition
Midazolam Hydrochloridemidazolam hydrochlorideInjectable;InjectionBd RxApproval
Minocycline Hydrochlorideminocycline hydrochlorideTablet, Extended Release;OralMylan Pharms IncApproval
Minocycline Hydrochlorideminocycline hydrochlorideTablet, Extended Release;OralMylan Pharms IncTentative Approval
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.22% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Potassium Chloride 0.3% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
PrinivillisinoprilTablet;OralMerckManufacturing Change or Addition
Rivastigmine Tartraterivastigmine tartrateCapsule;OralMacleods Pharms LtdApproval
Theophylline 0.04% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
Theophylline 0.08% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
Theophylline 0.16% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
Theophylline 0.2% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
Theophylline 0.32% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
Theophylline 0.4% and Dextrose 5% In Plastic ContainertheophyllineInjectable;InjectionB BraunManufacturing Change or Addition
TobramycintobramycinSolution;Inhalation, NebulizerPulmoflow IncTentative Approval
Triumeqabacavir sulfate;dolutegravir;lamivudineTablet;Fixed-Dose, CombinatiionViiv HlthcareApproval
UcerisbudesonideTablet, Extended Release;OralSantarus IncManufacturing Change or Addition
ZorvolexdiclofenacCapsule;OralIroko Pharms LlcEfficacy Supplement with Clinical Data to Support