FDA Approves AMNEAL (AMRX) Generic of $983M Somatuline Depot, Launch Immediate
Amneal won FDA approval for lanreotide injection 120 mg/0.5 mL with Competitive Generic Therapy designation and is launching the product immediately.
Amneal Pharmaceuticals (AMRX) said the U.S. Food and Drug Administration has approved its lanreotide injection, 120 mg/0.5 mL, supplied in a sterile, single-dose prefilled syringe. The product references Ipsen's SOMATULINE Depot and will launch immediately, supported by in-house manufacturing. It received Competitive Generic Therapy designation from the agency.
