MUMBAI, India — The Food and Drug Administration has granted Glenmark Generics Inc. USA final approval for levonorgestrel/ethinyl estradiol tablets (0.09 mg/0.02 mg), an oral contraceptive.
Glenmark said Friday that its levonorgestrel/ethinyl estradiol tablets (0.09 mg/0.02 mg) are a generic version of Lybrel, which is no longer marketed in the United States.
Lybrel is indicated for the prevention of pregnancy. When the product was introduced in 2007 by Wyeth Pharmaceuticals, it was marketed as the first birth control pill that eliminates a woman’s monthly period.
According to IMS Health data reported by Glenmark, the Lybrel market had annual sales of about $6.4 million for the 12 months ended in February.
Glenmark said the approval of its generic product marks its 11th oral contraceptive authorized for distribution in the United States. The company plans to begin shipping the product immediately.