Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules



Several recent studies have suggested that common gene variations may be responsible for much of the elevated risk of kidney disease in African Americans. New research on the MYH9 gene-and its implications for the screening and possible prevention of kidney disease in the African American population-will be summarized in a press briefing to be held

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Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg.

Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s Sarafem(R) Pulvules(R) Capsules. This product had annual U.S. sales of approximately $19.2 million for the 12 months ending Sept. 30, 2008, for the noted strengths, according to IMS Health. Shipment of the product will begin immediately.

Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

http://www.mylan.com/

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Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis’ Lescol(R) Capsules. Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application

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Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules. Mylan

Full Post: Mylan confirms first-to-file patent challenge of AMRIX capsules



Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. Bupropion Hydrochloride Extended-Release Tablets is the generic equivalent to GlaxoSmithKline’s Wellbutrin XL(R) product,

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Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. have announced that they received approval from the European Commission to proceed with Teva’s acquisition of Barr. In connection with this approval, Teva and Barr are required to divest certain formulations of 17 generic drugs in certain specific countries with respect to which they have a product

Full Post: Teva and Barr receive European approval for acquisition



Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva’s U.S. generic version of AstraZeneca’s Pulmicort (Budesonide) Respules including all claims for patent infringement and damages. Teva launched its generic budesonide respules in the U.S. on November 18, 2008. The

Full Post: Teva announces agreement on generic Pulmicort Respules patent challenge