FDA re­jects Melin­ta, Ve­na­torx’s UTI an­tibi­ot­ic over CMC is­sues

The FDA hand­ed a CRL to Melin­ta Ther­a­peu­tics and Ve­na­torx Phar­ma­ceu­ti­cals for their uri­nary tract in­fec­tion an­tibi­ot­ic, with the agency call­ing for more in­for­ma­tion on chem­istry, man­u­fac­tur­ing and con­trols (CMC).

The FDA al­so re­quest­ed “re­lat­ed da­ta about the drug, test­ing meth­ods, and man­u­fac­tur­ing process,” ac­cord­ing to a Fri­day press re­lease. No new clin­i­cal tri­als are need­ed and no safe­ty or ef­fi­ca­cy is­sues were flagged, the com­pa­nies said.

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