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Gleolan Approval History

  • FDA approved: Yes (First approved June 6th, 2017)
  • Brand name: Gleolan
  • Generic name: aminolevulinic acid hydrochloride
  • Dosage form: Oral Solution
  • Company: NX Development Corp.
  • Treatment for: Optical Imaging During Glioma Surgery

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent indicated for use in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

Development History and FDA Approval Process for Gleolan

DateArticle
Jun  6, 2017Approval FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas

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