Mumbai, India (PressExposure) March 23, 2011 -- Glenmark Generics receives final approval from USFDA for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets.
Glenmark remains the only Indian company to be granted an ANDA approval for an oral contraceptive product in the US
Today's approval marks the fourth female hormonal product authorised for distribution in the US
Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (U.S. FDA) 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. According to IMS Health for the 12 month period ending December 2010, this combination achieved sales of USD 30 million.
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 U.S. FDA.
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 is approximately USD 141 million for the 12 month period ending December 2010, according to IMS Health.
Glenmark has a number of ANDA's currently pending approval with the U.S. FDA in this therapeutic segment as well as a sizeable concentration of their pipeline in various stages of development.
The Company's current portfolio consists of 69 generic products authorized for distribution in the U.S. market and over 40 ANDA's filed with the U.S. 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.