Glenmark gets USFDA approval for contraceptive drugs

New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for generic versions of Loestrin tablets, used to prevent pregnancy.

"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets, 1.5 mg/30 mcg)," the company said in a BSE filing.

The approved products are generic versions of Allergan Pharmaceuticals' Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets.

For the 12 months to April 2018, the Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets market achieved annual sales of approximately USD 24.2 million and USD 41.3 million respectively, Glenmark said, citing IQVIATM sales data.

The company's current portfolio consists of 137 products authorized for distribution at the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.