Cipla receives USFDA approval for Lanreotide Injection

Cipla USA Inc., wholly owned subsidiary of Cipla USA 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 USFDA.

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (lanreotide) Injection and is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEPNETs).

The approval for the generic version of Lanreotide Acetate is in line with Cipla's growth strategy in the complex product segment and will strengthen Cipla's position in the US market.

According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.

 

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