USFDA: New and Generic Drug Approvals: 25 NOV 2014

New and Generic Drug Approvals

November 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxilamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSandozLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet;OralApotex IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSun Pharma GlobalLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralActavis Labs Fl IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralMylanLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralAnchen PharmsLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralZydus Pharms Usa IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralJubilant GenericsLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralReddysLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Delayed Release;OralAurobindo Pharma LtdLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralAurobindo Pharma LtdLabeling Revision
LarotidamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
LucentisranibizumabInjectable; InjectionGenentechEfficacy Supplement with Clinical Data to Support
Norcoacetaminophen; hydrocodone bitartrateTablet;OralWatson LabsLabeling Revision
PriftinrifapentineTablet;OralSanofi Aventis UsEfficacy Supplement with Clinical Data to Support
TopiramatetopiramateCapsule;OralZydus Pharms Usa IncLabeling Revision
Tussicapschlorpheniramine polistirex; hydrocodone polistirexCapsule, Extended Release;OralEcr PharmaLabeling Revision

USFDA: New and Generic Drug Approvals: 24 NOV 2014

New and Generic Drug Approvals

November 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acanyabenzoyl peroxide; clindamycin phosphateGel;TopicalDow PharmEfficacy Supplement with Clinical Data to Support
Byettaexenatide syntheticInjectable;SubcutaneousAstrazeneca AbEfficacy Supplement with Clinical Data to Support
Diclofenac Sodiumdiclofenac sodiumSolution;TopicalPaddock LlcApproval
OptimarkgadoversetamideInjectable;InjectionMallinckrodtLabeling Revision
OptimarkgadoversetamideInjectable;InjectionMallinckrodtLabeling Revision
Optimark In Plastic ContainergadoversetamideInjectable;InjectionMallinckrodtLabeling Revision

USFDA: New and Generic Drug Approvals: 21 NOV 2014

New and Generic Drug Approvals

November 21, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adcetrisbrentuximab vedotinInjectable; InjectionSeattle GeneticsLabeling Revision
Cardizemdiltiazem hydrochlorideTablet;OralValeant IntlLabeling Revision
Hydrocodone Bitartrate and Homatropine Methylbromidehomatropine methylbromide; hydrocodone bitartrateSyrup;OralActavis Mid AtlanticLabeling Revision
Sensiparcinacalcet hydrochlorideTablet;OralAmgenEfficacy Supplement with Clinical Data to Support
Sensiparcinacalcet hydrochlorideTablet;OralAmgenLabeling Revision
Testosterone Enanthatetestosterone enanthateInjectable;InjectionHikma FarmaceuticaLabeling Revision


CFSAN Constituent Update - FDA Issues Final Menu and Vending Machine Labeling Requirements

The U.S. Food and Drug Administration has finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments and vending machines to help consumers make informed decisions about meals and snacks.

The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. 

A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. 

The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.

To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

Restaurants and similar retail food establishments that are covered, including those that voluntarily register with FDA to comply with the menu labeling requirements, will have one year from the date of publication of the menu labeling final rule to comply with the requirements.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

For more information CLICK HERE

USFDA: New and Generic Drug Approvals: 20 NOV 2014

New and Generic Drug Approvals

November 20, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aleve Pmdiphenhydramine hydrochloride; naproxen sodiumTablet;OralBayer HlthcareLabeling Revision
Aveloxmoxifloxacin hydrochlorideTablet;OralBayer HlthcareLabeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Containermoxifloxacin hydrochlorideInjectable;Iv (Infusion)Bayer HlthcareLabeling Revision
BiltricidepraziquantelTablet;OralBayer HlthcareManufacturing Change or Addition
CaracfluorouracilCream;TopicalValeant BermudaManufacturing Change or Addition
Dalvancedalbavancin hydrochlorideInjectable;Iv (Infusion)Durata Theraps IntlManufacturing Change or Addition
Depaconvalproate sodiumInjectable;InjectionAbbvieLabeling Revision
Depakenevalproic acidCapsule;OralAbbvieLabeling Revision
Depakenevalproic acidSyrup;OralAbbvieLabeling Revision
Depakotedivalproex sodiumTablet, Delayed Release;OralAbbvieLabeling Revision
Depakotedivalproex sodiumCapsule, Delayed Rel Pellets;OralAbbvieLabeling Revision
Depakote Erdivalproex sodiumTablet, Extended Release;OralAbbvieLabeling Revision
FinasteridefinasterideTablet;OralCipla LtdApproval
GliadelcarmustineImplant;IntracranialArbor Pharms LlcLabeling Revision
Hysingla Erhydrocodone bitartrateTablet, Extended Release;OralPurdue PharmaApproval
Isordilisosorbide dinitrateTablet;OralValeant BermudaManufacturing Change or Addition
Jenlogaclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncEfficacy Supplement with Clinical Data to Support
Kapvayclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncEfficacy Supplement with Clinical Data to Support
Locoid Lipocreamhydrocortisone butyrateCream;TopicalPrecision DermatLabeling Revision
PriftinrifapentineTablet;OralSanofi Aventis UsLabeling Revision
StendraavanafilTablet;OralVivusManufacturing Change or Addition

CDRH Industry: Guidance for Industry and Food and Drug Administration Staff - Design Considerations for Devices Intended for Home Use

This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. 

Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. 

This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.

To download the Document CLICK HERE

Health Canada : Consumer Product Update: Health Canada Warns of Fire Risk to Oxygen Therapy Patients from Electronic Cigarettes and Other Electrical Devices


Health Canada has been notified of an incident in the Province of Quebec resulting in an injury to a consumer from a fire associated with the use of an electronic cigarette in the presence of an oxygen source. 
According to the information currently available, the injured individual was undergoing oxygen therapy at the time of the incident. 
Health Canada is aware of similar incidents reported in other countries. Health Canada is working with the relevant authorities to further evaluate the incident in the Province of Quebec. 

For more information, please CLICK HERE

USFDA Recall - Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Complaints of Empty Capsules...

ISSUE: Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.

BACKGROUND: Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. Product was distributed through Northstar label to retail outlets nationwide.

RECOMMENDATION: Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase. Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more details on Recall CLICK HERE

FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties

The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.
Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given Hysingla ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management. As a single-entity opioid, Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen. The FDA encourages health care professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.
Strengths of Hysingla ER contain 20, 30, 40, 60, 80, 100 and 120 milligrams (mg) of hydrocodone to be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to people who have not previously taken an opioid medication (opioid non-tolerant). While Hysingla ER contains larger amounts of hydrocodone compared to immediate-release hydrocodone combination products, the range of tablet strengths of Hysingla ER is comparable to existing approved ER opioids. 
For more information on the Approval CLICK HERE