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Barr Receives Tentative Approval For Generic Mircette Oral Contraceptive.
2001 DEC 28 - (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…
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