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ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP
PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- 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. Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s ac...