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NDA accepted for filing by FDA for extended-regimen oral contraceptive.(Barr Laboratories Inc.'s new drug application for Seasonale oral contracptive accepted )(Brief Article)
2002 NOV 7 - (NewsRx.com & NewsRx.net) -- Barr Laboratories, Inc., (BRL) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for its Seasonale extended regimen oral contraceptive.
The company is seeking approval to manufacture and market Seasonale extended regimen oral contraceptive for the prevention of pregnancy. This represents the first NDA filing by the company.
"We are pleased to announce that our Seasonale NDA has been accepted by the FDA for review," said Dr. Carole S. Ben-Maimon, president and COO of Barr Research. "While acceptance for filing of an NDA does not assure approval, we believe our clinical data indicates that the Seasonale extended oral contraceptive therapy appears to prevent pregnancy and has a comparable safety profile to more traditional oral contraceptives. If granted final FDA approval, we expect that the Seasonale regimen will provide women with a choice in the area of birth control, especially those women who prefer the convenience of fewer ...
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Source: HighBeam Research, NDA accepted for filing by FDA for extended-regimen oral...