Barr Pharmaceuticals, Inc.

Tentative approval granted for generic version of Femhrt tablets

Published in Food and Drug Law Weekly, November 5th, 2004

Barr Pharmaceuticals, Inc., (BRL) announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Warner Chilcott's Femhrt (Norethindrone Acetate and Ethinyl Estradiol Tablets USP), 1 mg/0.005 mg.

The company anticipates receiving final approval and launching its version of Femhrt in November 2009, 6 months prior to the expiration of the patent on Femhrt, under the terms of the April 2004 agreement between Barr and Warner Chilcott (formerly Galen Holdings PLC). The company plans to market their generic product under the trade name Nevis.

Femhrt is...

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Source: Food and Drug Law Weekly (2004-11-05)

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