ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

Core Viewpoint - ANI Pharmaceuticals, Inc. has received FDA approval for its Naproxen Delayed-Release Tablets, marking a significant milestone in the company's product launch strategy and commitment to growth [1]. Company Overview - ANI Pharmaceuticals 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 expanding its Rare Disease business, enhancing its Generics business through improved R&D capabilities, and leveraging its U.S.-based manufacturing [2]. Product Launch and Market Potential - The FDA approval pertains to the Abbreviated New Drug Application (ANDA) for Naproxen Delayed-Release Tablets, which is a generic version of EC-Naprosyn® [1]. - The U.S. annual sales for Naproxen Delayed-Release Tablets are approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data [1].