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Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

The US FDA's Center for Drug Evaluation and Research (CDER) approved its third novel product of the year with a Feb. 13 blessing for Novartis AG's Egaten (triclabendazole), which also resulted in a priority review voucher for the Swiss drug giant. (See sidebar for related story.)

But the weak start for approvals this year continued to drag on, as the agency also issued its third complete response letter (CRL) for a novel product in 2019

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