New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for a generic version of Minastrin 24 tablets used for prevention of pregnancy.
“Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP and Ferrous Fumarate tablets, 1 mg/20 mcg, the generic version of Minastrin 24 Fe tablets,” the company said in a BSE filing.
The approved product is a generic version of Allergan Pharmaceuticals International Ltd’s Minastrin 24 Fe tablets.
For the 12 months to October 2017, the Minastrin 24 Fe tablets market achieved annual sales of approximately USD 337 million, Glenmark said, citing IQVIA sales data.
The company’s current portfolio consists of 130 products authorised for distribution in the US marketplace and 58 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.