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Barr Receives Tentative Approval For Generic Mircette Oral Contraceptive.(Brief Article)
2001 DEC 27 - (NewsRx.com & NewsRx.net) -- Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Mircette, Organon, Inc.'s, oral contraceptive. The application, which is the subject of a patent challenge that is expected to come to trial in calendar 2002, was acquired by Barr as part of its recent merger with Duramed Pharmaceuticals, Inc.
Mircette is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. The product has annual sales of $102 million for the most recent 12 months. Mircette is a 28-tablet regimen that represents a combination of desogestrel/ethinyl estradiol and ethinyl estradiol.
"Barr is committed to building a full line of generic oral contraceptive products. Challenging vulnerable patents protecting brand versions of select products is a component of that strategy," said Bruce L. Downey, Barr's chairman and CEO. "In addition to Mircette, we are also ...
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