Glenmark Generics Inc., (GGI) USA, a subsidiary of Glenmark Generics Ltd (GGL) today announced that they have been granted final approval for their Abbreviated New Drug Application (ANDA) by the United States Food and Drug Administration (US FDA) for norgestimate and ethinyl estradiol tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg.

Glenmark’s approved product is their generic version of Ortho Tri-Cyclen tablets by Ortho McNeil Janssen Pharmaceuticals Inc. indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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 triphasic 28-day regimen achieved total market sales of US$ 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 US FDA.

Glenmark has a number of ANDA’s currently pending approval 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 for distribution in the US market and 40 ANDA’s filed with the US FDA pending approval.