Lupin gets USFDA nod for generic contraceptive tablets

Drug firm Lupin today said it has received final approval from the US health regulator to market its generic Levonorgestrel and Ethinyl Estradiol combined oral contraceptive tablets.

The company’s subsidiary, Lupin Pharmaceuticals Inc, has received final approval from the United States Food and Drugs Administration (USFDA) to market these tablets in the strength of 0.15 mg/0.03 mg, it added.

The tablets are generic version of Teva Branded Pharmaceuticals Seasonale tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) in the same strength, Lupin said. According to IMS MAT June 2012 sales data, Seasonale tablets had annual US sales of nearly $81.2 million, it added.

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On the development, Lupin Corporate Spokesperson Shamsher Gorawara said: “Lupin’s current abbreviated new drug application (ANDA) filings for oral contraceptives stand at 30, which is the largest pipeline for the US OC market”.

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Company is marketing its Levonorgestrel and Ethinyl Estradiol tablets in 84 pink active tablets and 7 white inert tablets, Lupin said. The Mumbai based firm produces and develops a wide range of branded and generic formulations and active pharmaceutical ingredients (APIs).

The company is present in the cardiovascular, diabetology, asthma, pediatric, CNS and anti-infective segments, among others. Shares of Lupin Ltd today closed at Rs 574 per scrip on BSE, up 2.01 percent from its previous close.

PTI