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Glenmark Pharma’s drugs gets tentative ANDA approval

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The approvals are for norethindrone acetate and for adapalene and benzoyl peroxide gel

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food and Drug Administration (US FDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol tablets USP, 0.01 mg and Ferrous Fumarate tablets, 75 mg, the generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) tablets of Allergan Pharms Intl.

According to IMS Health sales data for the 12 month period ending February 2016, the Epiduo Gel market achieved annual sales of approximately $351.8 million.

Glenmark’s current portfolio consists of 112 products authorised for distribution in the US marketplace and 58 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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