Barr Laboratories, Inc., has received approval from the US 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 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, stated a company release.