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Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

 
• By Anju Ghangurde

Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.

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Avenue Under Strain After CRL for IV Tramadol • Source: Shutterstock

Avenue Therapeutics Inc. has received a Complete Response Letter from the US Food and Drug Administration for intravenous tramadol, potentially putting at risk the future of its share purchase transaction with InvaGen Pharmaceuticals Inc., a subsidiary of Indian company Cipla Limited.

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