Contraceptive tablets

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, has been granted final approval by the United States Food and Drug Administration (USFDA) for Norethindrone tablets 0.35mg, the drug maker’s generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc.

Norethindrone tablets are a progestin-only oral contraceptive for the prevention of pregnancy. This is Glenmark’s third female hormonal product approval and it is the second approval for an oral contraceptive. The company received approval in April 2010 for Heather tablets, their generic version of Watson’s Nor-QD tablets and the company also got approval for Norethindrone Acetate 5mg tablets.

Glenmark remains the only Indian company to be granted an abbreviated new drug applications (ANDA) approval for a female hormonal product and an oral contraceptive product. The US contraceptive market has historically been the largest of the seven major markets with sales reaching $4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health).

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