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



Scientists have identified 12 new genes that are somewhat strange bedfellows: Some link gallstones and blood cholesterol levels, others link melatonin and sleep patterns to small increases in glucose levels and larger jumps in the risk of diabetes. While these associations are surprising, all the genes are potential new drug targets and some of them

Full Post: Scientists find 12 new genes with potential as drug targets

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/

Link



--------------------------------------------------------------------------------------------
Related Posts:


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

Full Post: Mylan confirms generic Lescol patent challenge



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,

Full Post: Watson Pharmaceuticals receives FDA approval for generic Wellbutrin XL



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



Codexis, Inc. today announced a licensing agreement with Teva Pharmaceutical Industries Ltd., to produce an important publicly-undisclosed generic product, using a proprietary Codexis biocatalyst. Teva, the largest generic drug manufacturer in the world, is a leading producer of this generic product. The product is one of the largest- selling generic prescription drugs in the United

Full Post: Codexis announces licensing agreement with Teva Pharmaceutical Industries --------------------------------------------------------------------------------------------