Cipla announced that it has received final approval for its Lanreotide
Injection, from the United States Food and Drug Administration (US FDA). 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 singledose pre-filled syringes. It is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
The active ingredient, route of administration and strengths are the same as SOMATULINE DEPOT, from Ipsen Biopharmaceuticals Inc. According to IQVIA, SOMATULINE DEPOT had US sales of approximately $867M for the 12-month period ending October 2021.
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