FDA approves Barr extended-cycle oral contraceptive

10/27/2008

MONTVALE, N.J. The Food and Drug Administration has approved a Barr Pharmaceuticals subsidiary’s application for a new oral contraceptive, Barr said Monday.

The FDA approved Duramed Pharmaceuticals’ drug LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethynyl estradiol tablets).

Barr said the drug is the first lower-dose, extended-cycle oral contraceptive. Under the extended-cycle regimen, women take combination tablets containing 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol for 84 consecutive days, followed by tablets containing 0.01 mg of ethinyl estradiol for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.

“As a leader in women’s health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers,” Duramed chief executive officer Fred Wilkinson said.

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