IntelGenx Updates Status of Buprenorphine Buccal Film ANDA
SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) — IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
Related news for (IGXT)
- IntelGenx Provides Update on Previously Announced Sale and Investment Solicitation Process
- IntelGenx Obtains Preliminary Efficacy Results for the ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
- IntelGenx Announces Initiation of the Sale and Investment Solicitation Process
- IntelGenx Obtains Court-Approval of a Sale and Investment Solicitation Process
- IntelGenx Initiates Restructuring Proceedings Under the CCAA to Implement a Review of its Strategic Alternatives