Drugmaker Cipla on Wednesday announced that the US Food and Drug Administration (USFDA) has granted it final approval for the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Acromegaly is a hormonal disorder, while GEP-NETs is a rare type of tumour that can form in the pancreas or other parts of the gastrointestinal tract, including the stomach, small intestine, colon, rectum, and appendix.
The company said it has received final approval for Lanreotide injection in doses 120 mg/0.5 mL, 90 mg/0.3 mL, and 60 mg/0.2 mL.
It added that the USFDA approval is based on an Abbreviated New Drug Application (NDA).
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, and 60 mg/0.2 mL single-dose, pre-filled, and ready-to-inject syringe.
According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately $898 million in the last year, that is till March 2024.
