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ANI Pharmaceuticals Announces the FDA Approval and Launch of Nitrofurantoin Oral Suspension USP
BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":" BAUDETTE, Minn.--(BUSINESS WIRE)--\nANI 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) for Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.\n\n\nANI’s Nitrofurantoin Oral Suspension is the generic version of the Reference Listed Drug (RLD) Furadantin® Oral Suspension 25 mg/5 ml. The current annual U.S. market for Nitrofurantoin Oral Suspension is approximately $55.5 million, according to the latest estimates by IQVIA/IMS Health, a leading healthcare data and analytics provider.\n\n\n\"New product approvals and launches remain our top priority as we continue to grow our generics business. The FDA approval and commercialization of Nitrofurantoin Oral Suspension is another example of how we are continuing to bring limited-competition products to market, with the goal of serving the patient populations that can benefit,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.\n\n\nAbout ANI\n\n\nANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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. For more information, please visit our website www.anipharmaceuticals.com.\n\n\nForward-Looking Statements\n\n\nTo 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 mean...