From rxpgnews.com

Pharmacology
FDA Approves Kelnor(TM) as New Oral Contraceptive
By Barr Pharmaceuticals, Inc.
May 25, 2005, 20:36

Barr Pharmaceuticals, Inc. (NYSE: BRL) today 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(R) 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(TM) 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 diacetate and 35 mcg of ethinyl estradiol, and 7 white tablets of inert ingredients.

Kelnor is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Kelnor will compete in a market that had total annual sales of approximately $52 million for the twelve months ending March 2005, based on IMS sales data.

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