FDA concludes Treanda will benefit from Bendeka's exclusivity protection

FDA concluded that the scope of Orphan Drug exclusivity for cancer drug Bendeka bendamustine from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) extends to all applications containing the same active ingredient unless a sponsor shows clinical superiority to Bendeka. The decision bars approval of any ANDA referencing either Bendeka or Treanda bendamustine from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) until Dec. 7, 2022, even though Treanda’s Orphan Drug exclusivity period has expired.

Bendeka is a ready-to-dilute, 10-minute infusion formulation of bendamustine, an alkylating agent. Treanda requires 30-60 minutes for an infusion and more sodium chloride than Bendeka. Teva has U.S. rights to Bendeka from Eagle...