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news.Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg.
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The product is the generic version of Ortho Cyclen tablets by Janssen Pharmaceuticals.
The Norgestimate and Ethinyl Estradiol tablets are 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. 0.25/mg0.035mg garnered total market sales of around $88m for the twelve months ended December 2011, according to IMS Health data.