FDA de­ci­sion, launch of gas­troin­testi­nal drug de­layed af­ter ni­trosamine found in com­mer­cial batch­es

Take­da spin­out Phath­om Phar­ma­ceu­ti­cals’ lead gas­troin­testi­nal drug has hit a snag with the FDA, the com­pa­ny an­nounced Tues­day, and won’t hit the mar­ket un­til af­ter the first quar­ter of 2023.

The FDA won’t take any ac­tion on the NDA for vono­prazan as a treat­ment of ero­sive esophagi­tis be­cause trace lev­els of ni­trosamine im­pu­ri­ties were found in com­mer­cial batch­es, Phath­om said.

Ac­cord­ing to the FDA, ni­trosamines can in­crease the risk of can­cer if pa­tients are ex­posed to them above the ac­cept­able lim­its for a long pe­ri­od of time.

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