Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd., has received final approval from the United States Food and Drug Administration (US FDA) for their abbreviated new drug application (ANDA) desogestrel and ethinyl estradiol tablets USP, 0.15 rngl0.02 mg and ethinyl estradiol tablets USP, 0.01 mg.
Glenmark will market their approved product as Viorele tablets and plan to commence shipping immediately.
Viorele tablets are Glenmark's generic version of Mircette tablets by Teva Women's Health Inc. Viorele is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
According to IMS Health for the 12 month period ending December 2011, the total market sales achieved for desogestrel & ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg were approximately US$ 98 million.
Today's approval marks Glenmark's ninth hormone/oral contraceptive 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 78 generic products authorized for distribution in the US market and 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.