Glenmark gets USFDA tentative nod for oral contraceptives
New Delhi : Glenmark Pharmaceuticals has received tentative nod from the US health regulator for generic version of oral contraceptive tablets Lo Loestrin Fe.
Glenmark Pharmaceuticals USA has been granted tentative approval by the USFDA for Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol tablets USP, 0.01 mg and Ferrous Fumarate Ferrous Fumarate tablets, 75 mg, the generic version of Lo Loestrin Fe, the company said in a BSE filing .
It further said: "Glenmark will market this product upon receiving the final approval. The patent listed in the Orange Book for Lo Loestrin Fe tablets is scheduled to expire on February 22, 2029."
According to IMS Health sales data for the 12 months to February 2016, Lo Loestrin Fe achieved annual sales of around $432.2 million, Glenmark said.
The company's current portfolio consists of 112 products authorised for distribution in the US marketplace and 57 Abbreviated New Drug Applications (ANDA) pending for approval with the USFDA.
Shares of the company were trading 0.58 per cent up at Rs 835.25 on BSE.