ANI Pharma gets US FDA nod for Nitrofurantoin Oral Suspension USP

ANI Pharmaceuticals has received US 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 US market for Nitrofurantoin Oral Suspension is approximately $55.5 million, according to the latest estimates by IQVIA/IMS Health.

“New product approvals and launches remain our top priority as we continue to grow our generics business. The FDA approval and commercialisation 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 CEO, ANI.