ANI obtains FDA OK for generic Divigel

ANI has received the Food and Drug Administration’s blessing for Estradiol Gel, 0.1%, which is the generic of Vertical Pharmaceuticals’ Divigel.

Estradiol Gel is indicated for the treatment of moderate to severe hot flashes due to menopause.

"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," said Nikhil Lalwani, president and CEO of ANI. "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.”

[Read more: ANI Pharmaceuticals launches 2 generics]

Estradiol Gel, 0.1%, has a market value of approximately $42.3 million, per IQVIA.

[Read more: ANI Pharmaceuticals receives FDA nod for generic Furadantin]