Glenmark Pharmaceuticals has received USFDA nod for oral contraceptive tablets Levonorgestrel and Ethinyl Estradiol. “Glenmark Generics Inc, 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 filing to the BSE.
Lybrel is indicated for prevention of pregnancy for those who go for oral contraceptives as a method of contraception, it said. The company said the approval marks Glenmark’s 11th oral contraceptive authorised for distribution by the USFDA. It plans to commence shipping of tablets Levonorgestrel and Ethinyl Estradiol, 0.09 mg/0.02mg immediately, stated the 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 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.