Tricida announces FDA acceptance of new drug application for veverimer

Tricida

14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for veverimer under the accelerated approval program. 

In its correspondence, FDA also stated that no filing review issues were identified. The FDA has assigned a Prescription Drug User Fee Act goal date of 22 August 2020 and indicated that it is currently planning to hold a Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the application.

The submission is supported by data from Tricida’s successful Phase 3 clinical trials that were recently published in back-to-back publications in The Lancet (March 2019 and June 2019).

Read Tricida press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier