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Cipla’s Avenue Receives Second CRL For Intravenous Tramadol

As Company Continues To Pursue FDA Approval For The Painkiller

Executive Summary

Cipla’s Avenue Therapeutics has received a second complete response letter from the US FDA regarding its new drug application for an intravenous formulation of tramadol. The company has disagreed with the FDA’s observations and said that it will continue to pursue regulatory approval for IV tramadol.

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