IntelGenx announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed, has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted abbreviated new drug application for Buprenorphine Buccal Film. The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time.
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