ANI: Approval and Launch of Estradiol Gel, 0.1%

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.

ANI’s Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel^®. The current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA, a leading healthcare data and analytics provider.

https://www.biospace.com/article/releases/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-estradiol-gel-0-1-percent-/