ANI Pharmaceuticals Wins FDA Approval for Generic Everolimus Tablets

MT Newswires Live

09/23

ANI Pharmaceuticals (ANIP) received final approval from the US Food and Drug Administration for its abbreviated new drug application for Everolimus Tablets for Oral Suspension in 2mg, 3mg and 5mg strengths, the company said Wednesday

The product is the generic version of Afinitor Disperz, with US annual sales of the reference product totaling about $123 million based on July 2026 moving annual total IQVIA data, the company said.

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