Tiny phar­ma hits a new low with FDA re­fus­ing to re­view com­pa­ny's re­sponse to its CRL

Just be­fore the long week­end, tiny Zosano Phar­ma re­vealed an­oth­er blow to its ap­pli­ca­tion for ap­proval for a mi­graine patch.

The FDA said the com­pa­ny’s re­sub­mis­sion for the patch didn’t ad­e­quate­ly re­spond to the de­fi­cien­cies iden­ti­fied in the FDA’s re­jec­tion let­ter, and that the agency will not re­view this re-sub­mit­ted ap­pli­ca­tion un­til a new com­plete re­sponse is sub­mit­ted.

Fre­mont, CA-based Zosano sent its re­sponse to the FDA last month, try­ing to res­ur­rect the gener­ic trip­tan zolmitrip­tan in a new de­liv­ery sys­tem known as Qtryp­ta. The agency in Oc­to­ber 2020 re­ject­ed the patch over in­con­sis­tent ex­po­sure lev­els across mul­ti­ple clin­i­cal tri­als, as well as oth­er is­sues.

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