1. Generics Bulletin

Cipla’s Avenue Receives Second CRL For Intravenous Tramadol

As Company Continues To Pursue FDA Approval For The Painkiller

 
• By Akriti Seth

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.

Arm Wrestle
Avenue and FDA lock horns over the regulatory approval of IV tramadol • Source: Alamy

Cipla’s Avenue Therapeutics Inc. has received a second complete response letter from the US Food and Drug Administration regarding its 505(b)(2) new drug application for its intravenous formulation of painkiller, IV tramadol. However, Avenue said that it disagrees with the FDA’s interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.

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