Lupin receives USFDA approval for oral contraceptive tablets
Lupin’sKurvelo tablets aim to take a slice of US$ 5 billion worth oral contraceptive market in the US.
New Delhi, October 18, 2012: Lupin has received approval from US Food and Drugs Administration (USFDA) for its oral contraceptive Kurvelo tablets. It is worth noting here that Lupin’sKurvelo tablets are the generic equivalent of Teva'sNordette tablets and are indicated for the prevention of pregnancy in women.
"Lupin is marketing its Kurvelo tablets in 21 light orange coloured active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinylestradiol and seven pink inert tablets (without hormones)," the company said in a statement.
The oral contraceptive (OC) market in the US is valued at over US$ 5 billion and is 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.