Glenmark receives tentative approval from US FDA for birth control pills

Glenmark Pharmaceuticals has received tentative approval from the US Food & Drug Administration (FDA) for norethindrone acetate and ethinyl estradiol tablets (1 mg/0.01 mg), ethinyl estradiol tablets (0.01 mg) and ferrous fumarate tablets (75 mg) - the generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) tablets of Allergan Pharms Intl. Lo Loestrin Fe is used for birth control.
 
Glenmark will market this product upon receiving final approval from the US FDA. The patent listed in the Orange Book for Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) tablets is scheduled to expire on February 2, 2029.
   
According to IMS Health sales data for the 12 month period ending February 2016, the Lo Loestrin Fe market achieved annual sales of approximately $ 432.2 million.