ANI Pharmaceuticals Wins FDA Approval for Generic Everolimus Tablets

ANI Pharmaceuticals Inc. (ANIP) said the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for Everolimus Tablets for Oral Suspension in 2mg, 3mg and 5mg strengths. The product is a generic version of Novartis' Afinitor Disperz. The approval adds a new generic oncology asset to ANI's commercial portfolio. The company did not disclose pricing, launch timing, or projected revenue for the product. ANI shares trade on the Nasdaq under the ticker ANIP.