Generic Drug News

Amneal Pharmaceuticals Receives Five Generics Industry Awards For Customer Value And Service Excellence

07/27/2010

Amneal Pharmaceuticals announced that the company has been honored with the Distribution Industry Award for Notable Achievements in Healthcare (DIANA) for Best Generic Product Manufacturer with Sales to Healthcare Distributors of Less Than $100 Million by the Healthcare Distribution Management Association (HDMA). The award recognizes pharmaceutical manufacturers who set the standard of excellence in best business practices with HDMA healthcare distributors. HDMA members independently voted for companies they believed demonstrated overall exceptional performance as a generics manufacturer and supplier.More »

Amneal Pharmaceuticals

FDA Approves First Generic Enoxaparin Sodium Injection to Prevent DVT

07/23/2010

The U.S. Food and Drug Administration approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.

Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.More »

enoxaparin, FDA, Lovenox

Mylan Receives Approval for Generic Version of Catapres-TTS®

07/20/2010

Mylan Inc. announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS®, a treatment for hypertension.

Clonidine Transdermal System had U.S. sales of approximately $313 million for the 12 months ending March 31, 2010, according to IMS Health. The product is available for immediate shipment.More »

Mylan

Teva Introduces Naratriptan Tablets USP

07/14/2010

Teva Pharmaceuticals is pleased to announce the introduction and availability of Naratriptan Tablets USP. This product is AB rated and bioequivalent to Amerge®* Tablets. Naratriptan Tablets are available in 1 mg and 2.5 mg strengths, in 9 x 1
Blister Packs.More »

Teva

Fougera® Announces First Generic Approval of Adapalene Cream 0.1% (Rx), Equivalent to Differin®

07/06/2010

E. Fougera & Co. announced it has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx). Fougera's Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million.More »

Fougera

Lupin Receives FDA Approval for Famotidine for Oral Suspension

07/01/2010

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the US Food and Drug Administration (FDA) for its Famotidine for Oral Suspension (40 mg / 5 mL). Commercial shipments of the product have already commenced.

Lupin's Famotidine for Oral Suspension is the AB-rated generic equivalent of Merck's *PEPCID® indicated for the short-term treatment of active duodenal ulcer, active benign gastric ulcer, and gastroesophageal reflux disease (GERD). PEPCID for Oral Suspension had annual sales of approximately $29 million for the twelve months ended March 2010, based on IMS Health sales data.More »

famotidine, Lupin Pharmaceuticals

PAR Pharmaceutical Begins Shipment of Generic ZEGERID®

07/01/2010

Par Pharmaceutical Companies, Inc. announced that it began shipping the 20mg/1100mg and 40mg/1100mg strengths of omeprazole and sodium bicarbonate capsules to the trade. Omeprazole and sodium bicarbonate capsules are the generic version of Santarus’ Zegerid®. Annual U.S. sales of Zegerid capsules are approximately $195 million, according to IMS Health data. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these strengths of the product.

On April 14, 2010, the District Court of Delaware held that the patents covering Zegerid are invalid. The case is currently on appeal at the Court of Appeals for the Federal Circuit.More »

esophagitis, GERD, omeprazole, Par Pharmaceutical, Zegerid

Teva Introduces Anastrozole Tablets

06/29/2010

Teva Pharmaceuticals is pleased to announce the introduction and availability of Anastrozole Tablets. This product is AB rated and bioequivalent to Arimidex®* Tablets. Anastrozole Tablets are available in 1 mg strength, in bottle sizes of 30.

“Our global investment in new product development continues to pay dividends,” states Maureen Cavanaugh, V.P., Customer Operations & Marketing. “Our vertical integration provides us with a strategic advantage that ensures that customers have a consistent, reliable source of the products they need.”More »

Teva

Mylan Receives Approval for Generic Version of Procardia XL® Tablets

06/24/2010

Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL® Tablets, a treatment for angina and/or hypertension.

Nifedipine Tablets had U.S. sales of approximately $234 million for the 12 months ending March 31, 2010, according to IMS Health.More »

Mylan

Roxane Laboratories, Inc. Announces Approval of Valacyclovir Hydrochloride Tablets 500mg and 1g

06/15/2010

Roxane Laboratories, Inc. announced the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and 1g as of May 24, 2010 by the Food and Drug Administration.

Valacyclovir Hydrochloride Tablets are a nucleoside analogue DNA polymerase inhibitor indicated for use in adult patients for the following: Cold Sores (Herpes Labialis), Genital Herpes (treatment of initial or recurrent episodes in immunocompetent patients, suppression in immunocompetent or HIV-infected patients, and reduction of transmission), and Herpes Zoster. Valacyclovir Hydrochloride Tablets are also indicated for use in pediatric patients for the treatment of Cold Sores (Herpes Labialis). The efficacy and safety of Valacyclovir Hydrochloride Tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients. Roxane Laboratories, Inc. Valacyclovir Hydrochloride Tablets 500mg and 1g, bottles of 30 are available for immediate shipment to wholesalers and pharmacies nationwide.More »

Roxane Laboratories, Valacyclovir

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