Barr Pharmaceuticals (BRL) Receives FDA Approval for Generic Yasmin
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Barr Pharmaceuticals, Inc. (NYSE: BRL) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
On March 3, 2008 Barr announced that the U.S. District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the U.S. Court of Appeals for the Federal Circuit.
Yasmin is a 28-day oral contraceptive consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. [SM]
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