Glenmark Generics Inc., USA, a subsidiary of Glenmarlc 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 Norgestimate and Ethinyl Estradio1 tablets, USP 0.18 mg /O.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg.
Glerimark’s approved product is their generic version of Ortho Tri-Cyclen® tablets by Ortho McNeil anssen’Pharmaceutioals Inc. indicated for the prevention of pregnancy in women who elect to use oral eonftaceptives as a method of contraception. Norgestimate and Ethinyl Estradiol Tablets USP are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no’ known contraindications to oral contraceptive therapy and have achieved menarche.
According to IMS Health for the 12 month period ending March 2011, this tripbasic 28-day regimen achieved total market sales of USD 226 million.
Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and today’s approval marks their fifth female hormonal product authorized for distribution by the U.S. FDA.
Glenmark has a number of ANDA’s currently pending approvl with the US. 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 ibm distribution in the U.S. marlct and’ 40 ANDA’s filed with the U.S. FDA pending approval. In addition to these internal filirigs’, 001 continues to identili’ and explore external development partnerships to supplement and accelerate the. growth of the existing pipeline and portfolio.