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      Glenmark Generics gets USFDA approval for Norethindrone

      Posted AtBusiness-Standard.com

      Glenmark Generics Inc, US, a subsidiary of Glenmark Generics Ltd, announced on Friday that they have been granted final approval by the US Food and Drug Administration (USFDA) for Norethindrone tablets 0.35mg, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc.

      Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy. Total sales of this niche generic contraceptive product were $43 million for the 12 month period ending March 2010, according to IMS Health.

      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 received approval for Norethindrone Acetate 5mg tablets on Thursday.

      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).

      Glenmark already has existing ANDAs pending approval with the USFDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.

      July 30, 2010


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