Drug firm Lupin today said its subsidiary has received American health regulator’s approval to market its generic oral contraceptive tablets ‘Kurvelo’ in the US market.
The company’s subsidiary — Lupin Pharmaceuticals Inc has received final approval from US Food and Drugs Administration (USFDA) for its oral contraceptive Kurvelo tablets, Lupin Ltd said in a statement.
Lupin’s Kurvelo tablets are the generic equivalent of Teva’s Nordette tablets and are indicated for the prevention of pregnancy in women, it added.
“Lupin is marketing its Kurvelo tablets in 21 light orange coloured active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl estradiol and seven pink inert tablets (without hormones),” the company said.
According to industry sources, the oral contraceptive (OC) market in the US is valued at over $5 billion and growing at around 8 per cent annually.
Lupin’s current abbreviated new drug application (ANDA) filings for OC’s stand at 30 — which is the largest pipeline for the US OC market.
Headquartered in Baltimore, Lupin Pharmaceuticals Inc is the wholly owned subsidiary of Mumbai-based Lupin Ltd.
Lupin scrip was at Rs 571.80 on the BSE in the late afternoon trade, up 0.04 per cent from its previous close.