Glenmark gets USFDA final nod for contraceptive tablets

NEW DELHI: Glenmark Pharmaceuticals has received final nod from the US health regulator for generic oral contraceptive Levonorgestrel/Ethinyl Estradiol tablets and plans to commence shipping of the product immediately.

Glenmark Pharmaceuticals USA has been granted final approval by the United States Food & Drug Administration (USFDA) for the "extended-cycle oral contraceptive Levonorgestrel and Ethinyl Estradiol tablets USP 0.15 mg/0.03 mg," Glenmark Pharmaceuticals said in a statement.

The product is the generic version of Teva Women's Health's Seasonale tablets, it added.

According to IMS Health sales data for the 12 months to April 2015, the Seasonale brand and all available therapeutic equivalents registered annual sales of around USD 53.7 million, Glenmark said.

Today's approval marks the company's 12th oral contraceptive and second extended-cycle oral contraceptive authorised for distribution by the US health regulator.

The company's current portfolio consists of 99 products authorised for distribution in the US marketplace and 66 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

Glenmark Pharmaceuticals was today trading at Rs 889 in the afternoon trade on BSE, up 1.02 per cent.