Pharma Focus America

ANI Pharmaceuticals Announces the FDA Approval and Launch of Nitrofurantoin Oral Suspension USP

Tuesday, April 25, 2023

ANI Pharmaceuticals, Inc., 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.

ANI’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.

"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.



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