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A Question Of Identity: Drug & Botanical Perspectives On Manufacturing Clash In Fulyzaq Review

 
• By Bridget Silverman

Salix’ botanical product Fulyzaq tested the limits of the conventional small molecule chemistry approach to ensuring the identity of drug substance. After a regulatory briefing with CDER Director Woodcock, the botanicals and CMC review teams agreed on a bioassay to bridge the gap in their regulatory perspectives.

A bioassay ultimately bridged conflict between the Office of New Drug Quality Assessment and the Botanical Review Team over the adequacy of product characterization in Salix Pharmaceuticals Ltd.’s Fulyzaq (crofelemer) NDA, review documents show – but only after the dispute was adjudicated by CDER Director Janet Woodcock.

“Late phase development of botanical new drugs remains a rarity and review experience with botanical NDAs is limited,” lead botanical...

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