Register for Extended-cycle oral contraceptive now available in U.S.
ContraceptionNovember 20, 2003
2003 NOV 20 - (NewsRx.com & NewsRx.net) -- Barr Laboratories, Inc. (NBRL) announced that the company's Seasonale product, the first and only U.S. Food and Drug Administration (FDA)-approved extended-cycle oral contraceptive indicated for the prevention of pregnancy, is now available to U.S. women in pharmacies nationwide.
"Our approval of this revolution in oral contraception garnered unparalleled media attention, particularly when compared with the recent launch of other well-known products," said Bruce L. Downey, Barr's chairman and chief executive officer.
"Based on our market research, we expect that when our women's healthcare sales force begins physician detailing of this exciting new option for oral contraception, awareness and usage among target physicians will rapidly grow."
Beginning in mid-November 2003, Seasonale will be promoted directly to physicians and healthcare providers by Duramed Pharmaceuticals, Inc.'s 250 person women's healthcare sales force. Duramed is a wholly owned subsidiary of Barr Laboratories, Inc.
"In addition to offering women a new choice in contraception, Seasonale is our first internally developed New Drug Application (NDA) to gain FDA approval," Downey added. "We expect Seasonale will be the first of several additional new drug applications for women's healthcare products over the next several years, and are currently discussing with FDA the submission of a supplemental NDA for a lower dose Seasonale product during the current fiscal year."
"Seasonale is a 91-day regimen taken daily as 84 active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol, followed by 7 inactive tablets," explained Dr. Carole Ben-Maimon, president and chief operating officer of Barr Research.
"The Seasonale regimen is designed to reduce the number of periods from 13 to 4 per year. By contrast, oral contraceptive products currently available in the United States are based on a 28-day regimen."
Barr Laboratories, Inc. is engaged in the development, manufacture, and marketing of generic and proprietary pharmaceuticals. This article was prepared by Women's Health Weekly editors from staff and other reports.
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