Barr Pharmaceuticals, Inc. has announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Wyeth Pharmaceuticals Inc.'s Effexor (Venlafaxine Hydrochloride) Tablets, 25mg, 37.5mg, 50mg, 75mg and 100mg.
A tentative approval reflects FDA's determination that a generic product satisfies the requirements for final approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
The Company's Abbreviated New Drug Application (ANDA) containing a Paragraph III certification was filed with the FDA for Wyeth's Effexor (Venlafaxine Hydrochloride) Tablets, 25mg, 37.5mg, 50mg, 75mg and 100mg on September 29, 2006. The pediatric exclusivity attached to the patent protecting Effexor is scheduled to expire on June 13, 2008, and the Company anticipates receiving final approval and marketing the product upon the expiration of that exclusivity.
Effexor is indicated for the treatment of major depressive disorder. The total market for Venlaxafine Hydrochloride tablets, expressed as the base 25mg, 37.5mg, 50mg, 75mg and 100mg, had annual sales of approximately $182.8 million for the twelve months ending April 2007, according to IMS sales data.