Cipla Limited (hereafter referred to as “Cipla”) and its subsidiary Cipla USA, Inc. announced on Sunday that the United States Food and Drug Administration had given final approval to their Lanreotide Injection (US FDA). The FDA granted approval based on a New Drug Application (NDA) filed through the 505(b)(2) process. Single-dose pre-filled syringes of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL Lanreotide Injection are available. Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors are among the conditions for which it is prescribed (GEP-NETs).
“We are pleased to receive the final approval for Lanreotide injection from the USFDA. Enabling access to high-quality treatments is core to our purpose of “Caring for Life,” Umang Vohra (MD and Global CEO, Cipla Limited) said.
This approval is a big step forward for our US operations, and it aligns with our desire to expand our complex product pipeline and meet unmet patient needs. SOMATULINE DEPOT®, from Ipsen Biopharmaceuticals Inc., has the same active component, method of administration, and strengths. SOMATULINE DEPOT had US sales of $867 million in the 12-month period ending October 2021, according to IQVIA.