USFDA: New and Generic Drug Approvals: 25 NOV 2014

New and Generic Drug Approvals

November 25, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amoxil	amoxicillin	For Suspension;Oral	Dr Reddys Labs Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Sandoz	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet;Oral	Apotex Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Sun Pharma Global	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Actavis Labs Fl Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Mylan	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Anchen Pharms	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Zydus Pharms Usa Inc	Labeling Revision
Bupropion Hydrochloride	bupropion hydrochloride	Tablet, Extended Release;Oral	Jubilant Generics	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Extended Release;Oral	Reddys	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Delayed Release;Oral	Aurobindo Pharma Ltd	Labeling Revision
Divalproex Sodium	divalproex sodium	Tablet, Extended Release;Oral	Aurobindo Pharma Ltd	Labeling Revision
Larotid	amoxicillin	For Suspension;Oral	Dr Reddys Labs Inc	Labeling Revision
Lucentis	ranibizumab	Injectable; Injection	Genentech	Efficacy Supplement with Clinical Data to Support
Norco	acetaminophen; hydrocodone bitartrate	Tablet;Oral	Watson Labs	Labeling Revision
Priftin	rifapentine	Tablet;Oral	Sanofi Aventis Us	Efficacy Supplement with Clinical Data to Support
Topiramate	topiramate	Capsule;Oral	Zydus Pharms Usa Inc	Labeling Revision
Tussicaps	chlorpheniramine polistirex; hydrocodone polistirex	Capsule, Extended Release;Oral	Ecr Pharma	Labeling Revision

USFDA: New and Generic Drug Approvals: 24 NOV 2014

New and Generic Drug Approvals

November 24, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acanya	benzoyl peroxide; clindamycin phosphate	Gel;Topical	Dow Pharm	Efficacy Supplement with Clinical Data to Support
Byetta	exenatide synthetic	Injectable;Subcutaneous	Astrazeneca Ab	Efficacy Supplement with Clinical Data to Support
Diclofenac Sodium	diclofenac sodium	Solution;Topical	Paddock Llc	Approval
Optimark	gadoversetamide	Injectable;Injection	Mallinckrodt	Labeling Revision
Optimark	gadoversetamide	Injectable;Injection	Mallinckrodt	Labeling Revision
Optimark In Plastic Container	gadoversetamide	Injectable;Injection	Mallinckrodt	Labeling Revision

USFDA: New and Generic Drug Approvals: 21 NOV 2014

New and Generic Drug Approvals

November 21, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Adcetris	brentuximab vedotin	Injectable; Injection	Seattle Genetics	Labeling Revision
Cardizem	diltiazem hydrochloride	Tablet;Oral	Valeant Intl	Labeling Revision
Hydrocodone Bitartrate and Homatropine Methylbromide	homatropine methylbromide; hydrocodone bitartrate	Syrup;Oral	Actavis Mid Atlantic	Labeling Revision
Sensipar	cinacalcet hydrochloride	Tablet;Oral	Amgen	Efficacy Supplement with Clinical Data to Support
Sensipar	cinacalcet hydrochloride	Tablet;Oral	Amgen	Labeling Revision
Testosterone Enanthate	testosterone enanthate	Injectable;Injection	Hikma Farmaceutica	Labeling 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 Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aleve Pm	diphenhydramine hydrochloride; naproxen sodium	Tablet;Oral	Bayer Hlthcare	Labeling Revision
Avelox	moxifloxacin hydrochloride	Tablet;Oral	Bayer Hlthcare	Labeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Container	moxifloxacin hydrochloride	Injectable;Iv (Infusion)	Bayer Hlthcare	Labeling Revision
Biltricide	praziquantel	Tablet;Oral	Bayer Hlthcare	Manufacturing Change or Addition
Carac	fluorouracil	Cream;Topical	Valeant Bermuda	Manufacturing Change or Addition
Dalvance	dalbavancin hydrochloride	Injectable;Iv (Infusion)	Durata Theraps Intl	Manufacturing Change or Addition
Depacon	valproate sodium	Injectable;Injection	Abbvie	Labeling Revision
Depakene	valproic acid	Capsule;Oral	Abbvie	Labeling Revision
Depakene	valproic acid	Syrup;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Tablet, Delayed Release;Oral	Abbvie	Labeling Revision
Depakote	divalproex sodium	Capsule, Delayed Rel Pellets;Oral	Abbvie	Labeling Revision
Depakote Er	divalproex sodium	Tablet, Extended Release;Oral	Abbvie	Labeling Revision
Finasteride	finasteride	Tablet;Oral	Cipla Ltd	Approval
Gliadel	carmustine	Implant;Intracranial	Arbor Pharms Llc	Labeling Revision
Hysingla Er	hydrocodone bitartrate	Tablet, Extended Release;Oral	Purdue Pharma	Approval
Isordil	isosorbide dinitrate	Tablet;Oral	Valeant Bermuda	Manufacturing Change or Addition
Jenloga	clonidine hydrochloride	Tablet, Extended Release;Oral	Concordia Pharms Inc	Efficacy Supplement with Clinical Data to Support
Kapvay	clonidine hydrochloride	Tablet, Extended Release;Oral	Concordia Pharms Inc	Efficacy Supplement with Clinical Data to Support
Locoid Lipocream	hydrocortisone butyrate	Cream;Topical	Precision Dermat	Labeling Revision
Priftin	rifapentine	Tablet;Oral	Sanofi Aventis Us	Labeling Revision
Stendra	avanafil	Tablet;Oral	Vivus	Manufacturing 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