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. 

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).

Pharma cipla usfda new drug application health news Biopharmaceuticals

American pharmaceutical market

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.