WOODCLIFF LAKE, N.J., Aug. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Warner Chilcott (US), Inc. in connection with Warner Chilcott's Femcon(R) FE (norethindrone and ethinyl estradiol) chewable oral contraceptive. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Femcon FE.
Barr filed its ANDA containing a paragraph IV certification for a generic Femcon FE product with the U.S. Food & Drug Administration (FDA) in April 2007, and received notification of the application's acceptance for filing in August 2007. Following receipt of the notice from the FDA, Barr notified Warner Chilcott, the New Drug Application (NDA) holder and patent owner.
On August 15, 2007, Warner Chilcott announced it had received a Paragraph IV certification notice for a generic version of its Femcon FE oral contraceptive from Barr Laboratories, Inc. Warner Chilcott indicated that it is evaluating the paragraph IV certification notice.
Femcon FE is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraceptive. The product had sales of approximately $16 million since it was launched in the U.S. in December 2006, based on IMS sales data ending June 2007.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical i
|SOURCE Barr Pharmaceuticals, Inc.|
Copyright©2007 PR Newswire.