Clinical Read2026-09-23

Everolimus

Amneal Pharmaceuticals Inc.AMRX
Indication
Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
Stage
phase6
Event
Approved
Details

Sept. 23, 2026: ANI Pharmaceuticals (NASDAQ: ANIP) announced final FDA approval of its ANDA for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths, the generic version of Afinitor Disperz. The approval is a regulatory catalyst for ANI’s U.S. generics business and enables launch of the product. The company said U.S. annual sales for everolimus tablets for oral suspension were about $123 million based on July 2026 moving annual total IQVIA data. ANI also stated it remains on track to launch at least 15 new generics in 2026.