Cipla receives final approval for the generic version of Somatuline Depot Injection

June 5, 2024 All

Cipla Limited and its wholly owned subsidiary Cipla USA, announced that it has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United States Food and Drug Administration (USFDA).
Cipla’s Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection. Lanreotide Injection is supplied as 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL single-dose, pre-filled, ready-to-inject syringe. Cipla’s Lanreotide injection is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.
Source: Indianpharmapost

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