Cipla gains USFDA approval for the generic version of Somatuline Depot (Lanreotide) injection
The new generic version to treat patients with GEP-NETs
Cipla and its wholly owned subsidiary Cipla USA (hereafter referred to as “Cipla”), 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 an 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), SomatulineDepot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.
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