Glenmark Pharma gets USFDA nod for oral contraceptives

PTI New Delhi | Updated on March 12, 2018

Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic oral contraceptives tablets.

The approval has been granted by the United States Food and Drug Administration (USFDA) to the company’s US arm Glenmark Generics Inc, a subsidiary of Glenmark Generics Ltd, Glenmark Pharmaceuticals said in a statement today.

The approvals are for the oral contraceptive products Norethindrone and Ethinyl Estradiol (Alyacen TM 1/35) tablets in different strengths.

The tablets are generic equivalents of Ortho-McNeil Janssen’s ‘Ortho-Novum 1/35-28’ tablets and ‘Ortho-Novum 7/7/7-28’ tablets.

The company claimed that according to IMS Health, these products achieved total market sales of nearly $ 96 million for the 12-month period ended September 30, 2011.

Glenmark’s current portfolio consists of 75 generic products authorised for distribution in the US market and 41 ANDAs filed with the USFDA pending approval.

Published on January 20, 2012

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