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.
