ANI Pharmaceuticals Announces the FDA Approval of Everolimus Tablets for Oral Suspension

PRINCETON, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), for Everolimus Tablets for Oral Suspension 2mg, 3mg and 5mg. ANI’s Everolimus Tablets for Oral Suspension are the generic version of the reference listed drug (RLD) Afinitor Disperz(®).

"The FDA approval of Everolimus Tablets for Suspension is another example of our R&D team's continued execution on technically demanding formulations, and the launch adds further momentum to our commercial portfolio. Our U.S. focused generics business continues to produce outstanding results, and we remain on track to launch at least 15 new generics this year,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.