FDA approves Aurobindo’s Loestrin generic line Aurovela

SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s Aurovela — its line of five generic Loestrin products. The line of oral contraceptives are indicated to prevent pregnancy.

The products include:

• 
  Aurovela Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, 1.5 mcg/30 mcg, and ferrous fumarate tablets, 75 mg), a Loestrin Fe generic;


• 
  Aurovela 24 Fe (norethindrone acetate and ethinyl estradiol tablets, 1 mcg/20 mcg, and ferrous fumarate tablets, 75 mg), a generic of Loestrin 24 Fe;


• 
  Aurovela Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, 1 mcg/20 mcg, and ferrous fumarate tablets, 75 mg), a generic of Loestrin Fe 1/20;


• 
  Aurovela 1/20 (norethindrone acetate and ethinyl estradiol tablets, 1 mcg/20 mcg); and


• 
  Aurovela (norethindrone acetate and ethinyl estradiol tablets, 1.5 mcg/30 mcg).

The combined products have a market size of $315.9 million for the 12 months ended May 2017 according to QuintilesIMS data.