Glenmark gets tentative nod for birth control pill Lo Loestrin Fe1 min read . Updated: 26 Apr 2016, 02:16 PM IST
Glenmark gets tentative nod from the USFDA for the generic version of Allergan's birth control pill Lo Loestrin Fe
Hyderabad: Glenmark Pharmaceuticals Ltd on Tuesday said it has got tentative nod from the US Food and Drug Administration (FDA) for the generic version of Allergan Inc.’s birth control pill Lo Loestrin Fe.
Lo Loestrin is generically called norethindrone acetate and ethinyl estradiol 1 mg/0.01 mg, ethinyl estradiol tablets 0.01 mg and ferrous fumarate tablets 75 mg.
Glenmark said it 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 22 February 2029.
According to US healthcare information provider IMS Health, for the 12 months to February 2016, Lo Loestrin Fe achieved annual sales of around $432.2 million.
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 FDA.
Shares of Glenmark declined 0.22% and were trading at ₹ 830.55 at 1.19pm on BSE, while the benchmark Sensex gained 1.11% and was trading at 25,963.97 points.