ANI Pharmaceuticals Receives Final FDA Approval Of Its Abbreviated New Drug Application For Everolimus Tablets For Oral Suspension

ANI Pharmaceuticals has received final FDA approval for its generic version of Everolimus Tablets for Oral Suspension in 2mg, 3mg, and 5mg dosages. The U.S. annual sales for the reference drug, Afinitor Disperz®, are approximately $123 million, according to July 2026 IQVIA data. ANI's CEO, Nikhil Lalwani, highlighted the approval as a testament to the R&D team's capabilities and indicated plans to launch at least 15 new generics this year.