Glenmark Generics Receives Approval From The USFDA For Norethindrone
Glemark's third product approval for hormones and second approval for oral contraceptives
Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted final approval by the United States Food and Drug Administration (U.S. 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 U.S. FDA along with additional products in various stages of development within this oral contraceptive therapeutic segment.
About Glenmark Generics limited.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India. Disclaimer"Glenmark Generics Limited ("Company") is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI. The Draft Red Herring Prospectus is available on the website of SEBI at www.sebi.gov.in and the respective websites of the BRLMs at www.enam.com and www.kmcc.co.in. Investors should note that investment in equity shares involves a high degree of risk and for details relating to the same, see the section titled "Risk Factors" of the aforementioned Draft Red Herring Prospectus."
SOURCE: Glenmark