 "Lupin gets US FDA approval to sell oral contraceptive")
Pharma firm Lupin Ltd said it has received US health regulator’s approval to sell generic version of oral contraceptive, Ortho Tri-cyclen Lo tablets in the American market.
The approval granted by the US Food and Drug Administration (USFDA) 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 filing to the BSE.
[caption id=“attachment_365462” align=“alignleft” width=“380” caption=“The approval granted by the US Food and Drug Administration (USFDA) is for multiple strengths of norgestimate. Reuters”]
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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 and it had sales of $421 million in the 12 months ended March 2012, the company said citing IMS Health sales data.
PTI