ANI Pharmaceuticals has received final FDA approval for its generic everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg strengths.
The approval covers ANI’s abbreviated new drug application, or ANDA, for products referencing Novartis’ Afinitor Disperz, the company said Sept. 23. ANI did not provide a launch date or pricing for the products.
Everolimus tablets for oral suspension are a generic version of the reference-listed drug Afinitor Disperz. The release did not detail the approved product’s labeled indications, dosing, safety information or potential market availability.
U.S. annual sales of everolimus tablets for oral suspension totaled approximately $123 million for the 12 months ended July 2026, according to IQVIA moving annual total data cited by ANI.
The approval adds to ANI’s U.S. generics portfolio. Chief Executive Officer Nikhil Lalwani said the company remains on track to launch at least 15 new generic medicines during 2026.
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