Brief: IntelGenx Receives Complete Response Letter From FDA For Rizaport NDA

Intelgenx Technologies

02/04/2019 13:11

April 2 (Reuters) - Intelgenx Technologies Corp  IGX.V :
    * INTELGENX RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR
RIZAPORT® NDA
    * INTELGENX TECHNOLOGIES CORP - ISSUES CITED IN CRL RELATE
TO
CHEMISTRY, MANUFACTURING AND CONTROLS SECTION OF APPLICATION
    * INTELGENX TECHNOLOGIES CORP - AGENCY REQUESTED ADDITIONAL
INFORMATION, BUT NO NEW BIOEQUIVALENCE STUDY.
    * INTELGENX TECHNOLOGIES - CONTINUES TO LOOK FORWARD TO
WORKING
WITH PARTNER, GENSCO PHARMA, TO COMMERCIALIZE RIZAPORT IN UNITED
STATES UPON FDA APPROVAL
    * INTELGENX TECHNOLOGIES - EXPECT TO RESUBMIT RIZAPORT NDA
BEFORE
END OF Q3-2019

Source text for Eikon:  ID:nGNX2RQVl6 
Further company coverage:  IGX.V 

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