Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market.
The company said it has received final approval for Lanreotide Injection from the US Food and Drug Administration (USFDA).
The FDA approval is based on new drug application (NDA), it added.
The Lanreotide injection is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Cipla MD and Global CEO Umang Vohra said, "This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs."
The company's product is generic equivalent of Ipsen Biopharmaceuticals Inc's Somatuline Depot.
According to IQVIA, Somatuline Depot had US sales of around USD 867 million for the 12-month period ended October 2021.
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