Theratechnologies hit with FDA refusal to file letter for intramuscular version of HIV drug

Ther­at­e­ch­nolo­gies was hit with a sec­ond set­back from the FDA this year as the agency hand­ed down a re­fusal to file let­ter for the com­pa­ny’s in­tra­mus­cu­lar ver­sion of its HIV drug Trog­a­r­zo.

The Mon­tre­al-based biotech said Tues­day that the FDA re­fused to file its sBLA for Trog­a­r­zo be­cause its Jan­u­ary fil­ing wasn’t “suf­fi­cient­ly com­plete” and “did not con­tain the da­ta re­quired to es­tab­lish the phar­ma­co­ki­net­ic bridge” be­tween the in­tra­mus­cu­lar and in­tra­venous ad­min­is­tra­tion of the drug.

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