ANI Pharma announces FDA approval and launch of Estradiol Gel, 0.1%

ANI Pharmaceuticals (NASDAQ:ANIP) received FDA approval for the abbreviated new drug application for Estradiol Gel, 0.1%, to treat and prevent hot flashes.

ANI’s Estradiol Gel, 0.1%, is the generic version of the reference listed drug, 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.

“The approval and launch of Estradiol Gel, 0.1%, mark an important milestone for ANI, as this is the first topical gel approved from our R&D and manufacturing site in New Jersey,” Nikhil Lalwani, president and CEO of ANI, said in a statement.

“This launch further highlights our efforts to bring limited-competition products to market and ensure that our high-quality products are readily accessible to our customers and patients in need,” he added.