PITTSBURGH, June 16 Mylan Inc. (NYSE: MYL) todayannounced that its subsidiary, Mylan Pharmaceuticals Inc., has received finalapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg(base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).
Venlafaxine HCl Tablets, indicated for the treatment of major depressivedisorder, are the generic version of Wyeth's Effexor(R) Tablets, which hadannual U.S. sales of approximately $188 million for the 12 months ending March31, 2008.
This product is shipping immediately. Currently, Mylan has 92 ANDAspending FDA approval, 20 of which are potential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among theleading diversified generic and specialty pharmaceutical companies in theworld. The company maintains one of the industry's broadest - and highestquality - product portfolios, supported by a robust product pipeline; owns acontrolling interest in the world's second largest active pharmaceuticalingredient manufacturer; and operates a specialty business focused onrespiratory and allergy therapies.
SOURCE Mylan Inc.