Friday, June 3, 2011

Mylan Receives Approval For Generic Version Of Effexor XR® Capsules

Mylan Receives Approval For Generic Version Of Effexor XR® Capsules

Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received ultimate approval from the U.S. Food and Drug Administration (FDA) ~ the sake of its Abbreviated New Drug Application (ANDA) on account of 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 put out of place. Mylan is launching these products through a antecedently announced settlement and license agreement entered into with Wyeth, which is now part of Pfizer.

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

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

No comments:

Post a Comment