Cipla and its subsidiary Cipla USA Inc., have received the final approval for Lanreotide injection from the United States Food and Drug Administration (USFDA).
The FDA approval was based on a New Drug Application (NDA) submitted under the 505 (b) (2) filing pathway. Lanreotide injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL single-dose pre-filled syringes. It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
Umang Vohra, the managing director (MD) and global chief executive officer (CEO) of Cipla, said, "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." 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 active ingredient, route of administration and strengths are the same as Somatuline Depot of Ipsen Biopharmaceuticals Inc. According to IQVIA data, Somatuline Depot had a US sales of approximately $867 million for the twelve-month period ending October 2021.
The drug major's consolidated net profit grew 7.6% year-on-year (Y-o-Y) to Rs 711.36 crore on 10.32% rise in net sales to Rs 5,485.84 crore in Q2 FY22 over Q2 FY21.
Shares of Cipla declined 2.40% to close at Rs 859.85 on Friday, 17 December 2021. Cipla is a global pharmaceutical company focused in India, South Africa, North America, and key regulated and emerging markets. Its strengths lies in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments.
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