FDA Approves Extended-Cycle Oral Contraceptive Seasonique
Filed in archive Drugs, Vaccines and Therapeutics on May 30, 2006
FDA Approves Extended-Cycle Oral Contraceptive Seasonique
The US FDA has approved Duramed Pharmaceuticals, Inc's New Drug Application (NDA) for Seasonique, a novel extended-cycle oral contraceptive. Seasonique is similar to the Seasonale, launched by the company in 2003, but differs in that instead of bearing 7 placebo pills, continuous hormonal support is provided in the form of low-dose estrogen ( 0.01 mg ethinyl estradiol). The regimen is also designed to reduce women's menstrual bleeding periods to four, instead of the usual 13.
Barr Pharmaceuticals, Inc, of which Duramed is a subsidiary, said that product labels have already been approved and Seasonique is expected to be available per prescription to end users by July 2006.
More details from Barr Pharmaceuticals' press release.
Tags: contraceptive hormones biotech seasonique oral contraceptive+seasonique cycle+oral oral+contraceptiv
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