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Physician Law Weekly

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Barr Pharmaceuticals, Inc.



Generic Demulen oral contraceptive tablets approved by U.S. FDA



June 22nd, 2005

Barr Pharmaceuticals, Inc., (BRL) announced that its subsidiary, Barr Laboratories, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market a generic version of Pfizer's Demulen 1/35-28 (Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1mg/35mcg) oral contraceptive.

The company will launch the product as a branded generic using the Kelnor trademark. The company's portfolio of generic oral contraceptives currently totals 22 products.

Kelnor 1/35 (28 day regimen) Tablets provide a continuous oral contraceptive regimen containing 21 light yellow tablets of 1 mg of ethynodiol...


Source: Physician Law Weekly (2005-06-22)

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