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Glenmark Pharmaceuticals receives ANDA approval for Levonorgestrel/ Ethinyl Estradiol Tablets USP

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Capital Market

From US FDA

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & 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 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 sales of approximately $53.7 million.

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First Published: Jun 15 2015 | 10:29 AM IST

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