Glenmark Generics’ (GGL) United States (US) subsidiary -- Glenmark Generics Inc., (GGI) -- has been granted final approval for its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc. The product will be marketed under the trade name Briellyn and distribution is expected to start immediately.
Briellyn provides a continuous 28 day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets and is indicated for the prevention of pregnancy. Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and today’s approval marks their fourth female hormonal product authorized for distribution by the USFDA.
The company received approval in April 2010 for Heather tablets, their generic version of Watson’s Nor-QD tablets as well as approvals in July 2010 for Norethindrone 0.35mg tablets, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc. and Norethindrone Acetate 5 mg tablets. Total market sales of Glenmark’s current hormonal product line are approximately $141 million for the 12 month period ending December 2010.
The company’s current portfolio consists of 69 generic products authorized for distribution in the U.S. market and approximately 40 ANDA’s filed with the US FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
Glenmark Generics (GGL) is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.
No comments:
Post a Comment