IntelGenx Technologies (IGXT) has released an update.
IntelGenx Corp. has announced that their partner, Xiromed LLC, received a Complete Response Letter from the FDA for the ANDA of Buprenorphine Buccal Film, a generic version of the pain management opioid Belbuca. The FDA has requested additional Pharmaceutical Quality information but confirmed no new inspections are needed at IntelGenx’s facility. The company’s CEO expressed commitment to addressing the FDA’s feedback promptly.
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