FDA approves generic version of estradiol gel for moderate to severe vasomotor symptoms due to menopause

The US Food and Drug Administration has approved generic version of estradiol gel Divigel for moderate to severe vasomotor symptoms during menopause.The FDA has granted abbreviated new drug application to ANI Pharmaceuticals according to a company press release.

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.

"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. 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,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

About ANI

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.