First AB Rated Oral Contraceptive Gains FDA Approval

Dateline 08/13/99

Duramed Pharmaceuticals, Inc. of Cincinnati, announced this week the FDA approval of its Abbreviated New Drug Application for Desogestrel and Ethinyl Estradiol 0.15 mg/0.03 mg--an oral contraceptive. The FDA granted the new drug bioequavalency, making it interchangeable with Ortho-Cept®, manufactured by R. W. Johnson Pharmaceutical, and Desogen™, manufactured by Organon Pharmaceutical.

Duramed expects to begin shipment within 60 days of the drug which is the first and only substitute equivalent oral contraceptive for Ortho-Cept and Desogen Tablets. The annual combined annual revenue in 1998 for the branded drugs was approximately $155 million. This drug will be available for all new prescriptions, as well as refills.

Duramed Chairman and CEO E. Thomas Arington stated in the company's press release, "Duramed is thrilled to receive this significant first approval as we continue to expand our efforts to become a leader in women's healthcare." Earlier this year Duramed gained approval for its drug Cenestin™ which is synthetic conjugated estrogens for the treatment of vasomotor symptoms associated with menopause. Duramed is also working to develop a pure isomer form of tamoxifen.

Duramed originally sought to gain approval for Cenestin as a generic equivalent for Premarin™. Approval as a generic was denied based on FDA regulations. According to the FDA drugs approved as a pharmaceutical equivalents are "drug products that contain identical amounts of the identical active drug ingredients, i.e., the same salt or ester of the same therapeutic moiety...that meet identical compendial or other applicable standards of identity, strength, quality, and purity, disintegration times and/or dissolution rates."

News of the approval of Desogestrel and Ethinyl Estradiol saw the company's stock (DRMD on the Nasdaq) soar from 1-7/8 to 11-7/8 in Thursday afternoon trading.

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