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ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate Tablets USP

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ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (“FDA”) approval for the Abbreviated New Drug Application (ANDA) for Fludrocortisone Acetate Tablets USP, 0.1 mg.

ANI’s Fludrocortisone Acetate Tablets are the generic version of the Reference Listed Drug (RLD) Florinef®. The current annual U.S. market for Fludrocortisone Acetate Tablets, 0.1 mg is approximately $24.2 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

“The commercialization of Fludrocortisone Acetate Tablets, the third generic to this RLD, continues to highlight the strength of our research and development engine and our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

About ANI

ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical 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. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.

View other recent FDA news here.

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