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Nirmal Bang Report
Cipla Ltd. has recently received final U.S. Food and Drug Administration approval for a complex injectable - Lanreotide Injection. The approval has come under the 505(b)(2) route and Cipla will need to promote the product with a sales force.
The product has the same active ingredient, route of administration and strengths as Somatuline, which currently generates ~$750 million annual sales in the U.S.
Cipla has received approval for two of the three indications that Somatuline is approved for. The company’s Lanreotide is approved for Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors, unlike Somatuline Depot, which is approved for an additional indication – Carcinoid syndrome.
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