Mylan Inc. Gets Tentative FDA OK on Antidepressant
PITTSBURGH, Nov. 17 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New 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 major depressive disorder and generalized anxiety disorder, are the generic version of Wyeth Pharmaceutical Inc.'s Effexor XR(R) Capsules. This product had annual U.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 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. For more information, please visit www.mylan.com.
CONTACT: Media: Michael Laffin, +1-724-514-1968, or Investors: Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
Web site: http://www.mylan.com/