FDA Approves Barr's Generic Demulen 1/35-28 Oral Contraceptive Tablets

Barr Pharmaceuticals has received FDA approval to manufacture and market a generic version of Pfizer's Demulen 1/35-28 (ethynodiol diacetate/ethinyl estradiol tablets USP, 1 mg/35 mcg) oral contraceptive.

The company will launch the product as a branded generic using the Kelnor trademark. Kelnor is indicated for the prevention of pregnancy in women. The branded generic will compete in a market that had total annual sales of approximately $52 million for the 12 months ending March 2005, Barr said.