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Lupin gets USFDA nod for generic oral contraceptive

Posted on Jul 03, 03:58PM | UNI

New Delhi, Jul 3 : Pharma firm Lupin Ltd today said it has received USFDA approval to sell generic version of oral contraceptive, Ortho Tri-cyclen Lo tablets in the US market.

'The approval granted by the US Food and Drug Administration (USFDA), the US health regulator, is for multiple strengths of norgestimate and ethinyl estradiol tablets in 0.18mg/0.025mg, 0.215 mg/0.025 mg and 0.25 mg/0.025mg, the company said in a regulatory filing.

Norgestimate and ethinyl estradiol (Ortho Tri-cyclen Lo) tablets are indicated for prevention of pregnancy, it said.

Ortho Tri-cyclen Lo is patented by Janssen Pharmaceuticals Inc.

According to IMS health data it had sales of 421 million dollars in the 12 months ended March 2012, it added.