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. 2023 Dec;63(4):702-703.
doi: 10.1007/s12088-023-01105-5. Epub 2023 Oct 3.

Takeaways from the Recarbrio Conundrum: Has the FDA Jumped the Gun?

Riddhi Kundu  1 , Sumit Roy Chowdhury  2
Affiliations

Takeaways from the Recarbrio Conundrum: Has the FDA Jumped the Gun?

Riddhi Kundu et al. Indian J Microbiol. 2023 Dec.

Abstract

Recarbrio is a novel antibiotic approved by US-FDA. It was initially found to be useful in treating various resistant gram negative infections. A recent investigation revealed lack of methodological and scientific integrity behind the process of FDA approval for this drug. This incident is a lesson for us that we shall not consider FDA clearance as the gold standard before approving any drug in the Indian market or start using it before having adequate data from our own clinical settings.

Keywords: Accelerated approval; Drug safety; FDA; Imipenem/cilastatin; Intraabdominal infection; Pneumonia; Recarbrio; Relebactam; U.S. Food and Drug Administration; Urinary tract infection; β-lactam/β-lactamase inhibitor.

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Conflict of interest statement

Conflict of interestAll authors declare no conflict of interest.

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