ANI Pharmaceuticals Announces Approval, Launch Of Estradiol Gel, 0.1%

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Estradiol Gel, 0.1%. It is the generic version of the Reference Listed Drug Divigel.

"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.

The company noted that the current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA.

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