Amneal Lanreotide Approved by US FDA
Amneal launches first CGT‑designated U.S. generic lanreotide — what NET patients need to know Amneal has launched the first Competitive Generic Therapy (CGT)‑designated U.S. generic for lanreotide, a major milestone in a market long dominated by Ipsen’s Somatuline® Depot. The product — lanreotide injection 120 mg/0.5 mL in a sterile single‑dose prefilled syringe — is FDA‑approved as a fully substitutable generic and is now commercially available through U.S. specialty distribution. Amneal announced the approval here. 1. Why Amneal’s approval matters Amneal’s lanreotide was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway — the strict 505(j) route used…
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