(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) announced Monday that it received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application or ANDA for Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.
ANI's Nitrofurantoin Oral Suspension is the generic version of the Reference Listed Drug Furadantin Oral Suspension 25 mg/5 ml.
According to the latest estimates by IQVIA/IMS Health, the current annual U.S. market for Nitrofurantoin Oral Suspension is around $55.5 million.
Nikhil Lalwani, President and Chief Executive Officer of ANI, said, "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."
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