Glenmark Pharma gets USFDA nod for oral contraceptives

Glenmark Pharmaceuticals has received approval form the US Food and Drug Administration (FDA) for oral contraceptive tablets Levonorgestrel and Ethinyl Estradiol.

"Glenmark Generics, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for the oral contraceptive Levonorgestrel and Ethinyl Estradiol tablets USP, 0.09 mg/0.02 mg, the therapeutic equivalent of Lybrel of Wyeth Phamaceutical Inc (which is no longer being marketed in the US)," Glenmark Pharma said in a Bombay Stock Exchange (BSE) filing.

Lybrel is indicated for prevention of pregnancy for those who go for oral contraceptives as a method of contraception, it said.

The drug manufacturer said the approval marks its 11th oral contraceptive authorised for distribution by the US drug authority.

Glenmark plans to commence shipping of tablets Levonorgestrel and Ethinyl Estradiol, 0.09 mg/0.02mg immediately, stated the BSE filing.

Glenmark's current portfolio consists of 97 products authorised for distribution in the US and 68 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.

The pharma company said it continues to identify and explore external development partnerships to supplement and accelerate growth of its existing pipeline and portfolio.

Glenmark Pharma shares were trading 1.42 per cent up at Rs 876.95 apiece during morning session on the BSE.