FDA approves Mylan's ANDA for Venlafaxine HCl ER Capsules to treat depressive, anxiety disorder

Jun 3 2011

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final 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), the generic version of Wyeth's Effexor XR® Capsules, which are used in the treatment of major depressive disorder and social anxiety disorder. Mylan is launching these products through a previously announced settlement and license agreement entered into with Wyeth, which is now part of Pfizer.

Venlafaxine HCl ER Capsules had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. The product is being shipped to customers.

Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.