Still no green light for Phath­om's gas­troin­testi­nal drugs af­ter im­pu­ri­ties found in batch­es

Phath­om Phar­ma­ceu­ti­cals is still work­ing out the kinks of launch­ing two al­ready-ap­proved drugs for a bac­te­r­i­al in­fec­tion and snag­ging an NDA ap­proval for an­oth­er gas­troin­testi­nal in­di­ca­tion af­ter im­pu­ri­ties were found in the first com­mer­cial batch­es.

Fol­low­ing of­fi­cial re­jec­tions, the Take­da spin­out plans to meet again with the FDA with­in the first quar­ter of this year to talk about the re­sub­mis­sion and time­line for an NDA for vono­prazan for ero­sive esophagi­tis as well as the launch of two drug com­bo treat­ments for He­li­cobac­ter py­lori (H. py­lori) bac­te­r­i­al in­fec­tions.

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