Lupin gets USFDA nod for generic oral contraceptive
Mumbai: Pharma company 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.
The company`s US-based subsidiary, Lupin Pharmaceuticals Inc., has received final approval from US Food and Drug Administration (USFDA) for its Levonorgestrel Tablets USP, 0.75 mg, Lupin said in a statement.
The 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.
Lupin entered the US oral contraceptives (OC) market in 2011 and has the largest OC pipeline for that market, with 32 filings with USFDA. It has received eight approvals so far.
The OC market in the US is valued at over $5 billion and growing at around 8 percent annually.
Lupin scrips closed at Rs 589.15 on the Bombay Stock Exchange, up 0.61 per cent from its previous close.
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