Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics Ltd, have been granted final approval by the United States Food and Drug Administration (US FDA) 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 USD 43 million for the 12 month period ending March 2010, according to IMS Health.
This is the 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 received approval for norethindrone acetate 5mg tablets yesterday. Glenmark remains the only Indian company to be granted an 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 USD 4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health)
Glenmark already has existing abbreviated new drug applications (ANDAs) pending approval with the US FDA along with additional products in various stages of development within this oral contraceptive therapeutic segment
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.