ANI Pharmaceuticals Wins FDA Approval for Generic Everolimus Tablets

ANI Pharmaceuticals Inc. (ANIP) received final FDA approval on September 23, 2026, for its generic Everolimus Tablets for Oral Suspension, a version of Novartis' Afinitor Disperz. The generic is indicated for certain conditions associated with tuberous sclerosis complex (TSC), a rare genetic disorder. The approval allows ANI to market a lower-cost alternative to the branded therapy. ANI did not disclose expected launch timing or pricing. The company's shares trade on the Nasdaq under the ticker ANIP.