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

2024-07-04

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July 02, 2024 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI’s Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®.

"We are pleased to announce the first cycle FDA approval and commercialization of Naproxen Delayed-Release Tablets. ANI remains committed to driving growth through superior new product launch execution, in keeping with our purpose of ‘Serving Patients, Improving Lives,’” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Naproxen Delayed-Release Tablets total approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

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. 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 U.S. based manufacturing footprint. For more information, visit www.anipharmaceuticals.com.

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