ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.06%

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, particularly for diseases with high unmet medical needs [2] - The company aims to achieve sustainable growth by scaling its Rare Disease business, enhancing its Generics business through improved research and development, and leveraging its U.S.-based manufacturing capabilities [2] Recent Developments - ANI Pharmaceuticals announced the launch of Estradiol Gel, 0.06%, following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) [1] - Estradiol Gel, 0.06% is the generic version of the reference listed drug EstroGel® Gel, 0.06% [1] - The U.S. annual sales for Estradiol Gel, 0.06% are approximately $16.7 million based on August 2024 moving annual total (MAT) IQVIA data [1]