New Delhi: Glenmark Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (US FDA) for generic versions of Loestrin tablets, a contraceptive pill.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (US FDA) 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),” Glenmark 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 Leostrin Fe 1.5/30 tablets market achieved annual sales of approximately $24.2 million and $41.3 million respectively, Glenmark said, citing IQVIATM sales data.
The company’s current portfolio consists of 137 products authorised for distribution in the US market and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the US FDA.
At 12.56pm, Glenmark shares were trading at Rs531.10, up 0.28%, on the BSE.