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Glenmark gets USFDA nod for Norgestimate, Ethinyl Estradiol

Glenmark Generics USA has got final approval from US Food and Drugs Administration (FDA) for their abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets.

June 20, 2011 / 15:05 IST
 
 
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Glenmark Generics USA has got final approval from US Food and Drugs Administration (FDA) for their abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets.


The approved product is the generic version of Ortho Tri-Cyclen tablets made by Ortho McNeil Janseen Pharmaceuticals, indicated for the prevention of pregnancy in women who choose to use oral contraceptives as a method of contraception, Glenmark said Monday.


Norgestimate and Ethinyl Estradiol tablets are also indicated for the treatment of moderate acne vlugaris in females at least 15 years of age who have no known contraindication to oral contraceptive therapy, it said.

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first published: Jun 20, 2011 11:14 am

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