Cipla Limited on Wednesday 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).
According to the company’s statement, 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 months ending March 2024.
