PITTSBURGH, Nov. 17 Mylan Inc. (NYSE: MYL) todayannounced that its subsidiary, Mylan Pharmaceuticals Inc., received tentativeapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl)Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg(base).
Venlafaxine HCl ER Capsules, indicated for the treatment of majordepressive disorder and generalized anxiety disorder, are the generic versionof Wyeth Pharmaceutical Inc.'s Effexor XR(R) Capsules. This product had annualU.S. sales of approximately $3 billion for the 12 months ending Sept. 30,2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which arepotential first-to-file opportunities.
Mylan Inc., which provides products to customers in more than 140countries and territories, ranks among the leading diversified generic andspecialty pharmaceutical companies in the world. The company maintains one ofthe industry's broadest -- and highest quality -- product portfolios,supported by a robust product pipeline; owns a controlling interest in theworld's third largest active pharmaceutical ingredient manufacturer; andoperates a specialty business focused on respiratory and allergy therapies.For more information, please visit www.mylan.com.
SOURCE Mylan Inc.