ANI Pharmaceuticals launches US FDA Approved Estradiol Gel

Overview

ANI Pharmaceuticals, Inc., a diversified biopharmaceutical company, announced that following final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the company launched estradiol gel, 0.06%. ANI’s estradiol gel, 0.06% is the generic version of the reference listed drug (RLD) EstroGel gel, 0.06%.

Statement from the CEO: ANI

With the FDA approval and commercialization of estradiol gel, 0.06%, we are pleased to bring another limited-competition product to market and ensure that customers and patients in need have ready access,” stated Nikhil Lalwani, president and chief executive officer of ANI.

US Annual Sales

US annual sales for estradiol gel, 0.06% total approximately $16.7 million, based on August 2024 moving annual total (MAT) IQVIA data.

About the Company: ANI Pharmaceuticals, Inc.

• ANI Pharmaceuticals, Inc. 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. 
• The company is focused on delivering sustainable growth by scaling up its rare disease business through its lead asset Purified Cortrophin gel, strengthening its generics business with enhanced research and development capabilities, delivering innovation in established brands, and leveraging its US based manufacturing footprint.

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