ANI Pharma wins FDA nod for generic Indocin

Grandbrothers/iStock Editorial via Getty Images ANI Pharmaceuticals ( NASDAQ: ANIP ) announced Tuesday the U.S. approval and market launch of Indomethacin, a generic version of the nonsteroidal anti inflammatory drug Indocin Oral Suspension (OS). The approval of ANIP’s Abbreviated New Drug Application (ANDA) allows the company to market Indomethacin Oral Suspension (OS), USP, in the U.S., where its annual market hovers around $4.1M, according to estimates from IQVIA ( IQV ).

With the approval, the company has also received a Competitive Generic Therapy (CGT) designation for Indomethacin OS from the FDA, with 180 day exclusivity. “ANI continues to hold the second highest number of CGT approvals in the U.S. Generics market, highlighting the strong capabilities and execution of our Generics R&D team,” Chief Executive Officer of ANI Pharmaceuticals ( ANIP ), Nikhil Lalwani, remarked.

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