Cipla gains FDA blessing for generic Somatuline Depot

The Food and Drug Administration has given Cipla its stamp of approval for lanreotide injection.

The medication is the generic of Ipsen’s Somatuline Depot. It is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumors.

[Read more: Cipla wins FDA OK for generic Imitrex]

The product is available in 60 mg/0.2 ml, 90 mg/0.3 ml and 120 mg/0.5 ml single-dose prefilled syringes.

“We are pleased to receive the final approval for Lanreotide injection from the FDA," said Umang Vohra, Cipla's global CEO. "Enabling access to high-quality treatments is core to our purpose of “Caring for Life.” This approval is a significant step for our U.S. business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs.”

[Read more: Cipla gets FDA nod for generic Migranal]

Somatuline Depot injection has a market value of approximately $867 million for the 12 months ending October 2021, according to IQVIA.