Glenmark's new generic drug gets FDA nod

Glenmark Pharmaceuticals receives ANDA approval for Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg

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This approval marks Glenmark's 12th oral contraceptive and 2nd extended-cycle oral contraceptive authorized for distribution by the US FDA

Glenmark Pharmaceuticals (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for the extended-cycle oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women's Health.

Seasonale is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending April 2015, the Seasonale market achieved annual sales of approximately $53.7 million.

This approval marks Glenmark's 12th oral contraceptive and second extended-cycle oral contraceptive authorized for distribution by the US FDA. The company plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.15 mg/0.03 mg immediately.

 

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