Glenmark Received US FDA Approval for Contraceptive Drug

Glenmark Received US FDA Approval for Contraceptive Drug

Glenmark Pharmaceuticals received final approval from the US Food and Drug Administration (FDA) on December 27, 2017, for a generic version of Minastrin 24 tablets used as a contraceptive 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. According to the Contraceptives Drugs report published by Coherent Market Insights, Contraceptive drugs aid in controlling birth rate and unintended pregnancies. Various drugs are used as contraceptives such as drosperinone. “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 of the company is a generic version of Allergan Pharmaceuticals International Ltd’s Minastrin 24 Fe tablets. Citing IQVIA sales data, Glenmark reported that, the 12 months to October 2017, the Minastrin 24 Fe tablets market achieved annual sales of approximately US$ 337 million. Company has wide range of portfolio, which consists of 130 products authorized for distribution in the U.S. market place and 58 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA. Glenmark Pharmaceuticals shares were trading at Rs 585, up 2.13% on the BSE.

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