Express Pharma

Glenmark gets US approval for Ashlyna extended-cycle oral contraceptive tablets


The company plans to commence shipping of Ashlyna immediately

Glenmark Generics, US, the subsidiary of Glenmark Generics announced the US market approval and introduction of Ashlyna (levonorgestrel/ethinyl estradiol and ethinyl estradiol) extended-cycle oral contraceptive tablets, the generic equivalent of Seasonique by Teva Women’s Health.

Seasonique is indicated for use by women to prevent pregnancy. According to IMS Health sales data for the 12 month period ending December 2014, the Seasonique market achieved annual sales of approximately $159.1 million.

The approval marks Glenmark’s 10th oral contraceptive and first extended-cycle oral contraceptive authorised for distribution by the US FDA. Glenmark plans to commence shipping of Ashlyna immediately.

Glenmark’s current portfolio consists of 94 products authorised for distribution in the US marketplace and 75 ANDA’s pending approval with the US FDA.

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