USFDA approval for Lupin`s generic oral contraceptive
New Delhi: Pharma firm Lupin Ltd today 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.
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 USD 421 million in the 12 months ended March 2012, the company said citing IMS Health sales data.
Shares of Lupin Ltd were trading at Rs 543.90 per share in the afternoon trade on BSE, up 0.09 per cent from previous close