Lupin gets USFDA nod for generic oral contraceptive drug
New Delhi: Drug firm Lupin Thursday said it has received approval from the US health regulator to market its oral contraceptive drug, Levonorgestrel Tablets USP, in the American market.
Lupin Pharmaceuticals Inc, the US-based subsidiary of the company, has received final approval from US Food and Drug Administration (USFDA) for its Levonorgestrel Tablets USP, 0.75 mg, Lupin Ltd said in a statement.
The company's product is the generic equivalent of Teva Branded Pharmaceutical Products R&D Inc's Plan B Tablets and is indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
According to IMS MAT September 2012 sales data, Plan B Tablets had annual sales of nearly USD 81.1 million in the US market.
Lupin entered the US oral contraceptives (OC) market in September 2011 and has the largest OC pipeline for the US market, with 32 filings with USFDA and has received eight approvals so far.
According to industry sources, the OC market in the US is valued at over USD 5 billion and growing at around 8 percent annually.
Headquartered in Baltimore, Lupin Pharmaceuticals Inc is the wholly owned subsidiary of Mumbai-based Lupin Ltd.
Lupin scrips closed at Rs 589.15 on the BSE, up 0.61 percent from its previous close.