Skip to Content

Orapred ODT Approval History

  • FDA approved: Yes (First approved June 1st, 2006)
  • Brand name: Orapred ODT
  • Generic name: prednisolone sodium phosphate
  • Dosage form: Orally Disintegrating Tablets
  • Company: BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc.
  • Treatment for: Asthma, acute

Orapred ODT is an orally disintegrating tablet formulation of prednisolone, used to treat exacerbations of asthma and other inflammatory diseases and conditions in children. Orapred ODT tablets are grape flavored and can be swallowed whole or allowed to dissolve in the mouth, with or without the assistance of water.

Development History and FDA Approval Process for Orapred ODT

Jun  1, 2006Approval Orapred ODT BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc. - Treatment for Asthma and other Inflammatory Conditions in Children
Oct 19, 2005BioMarin Announces U.S. FDA Acceptance of Orapred ODT Filing
Aug  1, 2005BioMarin Files New Drug Application for Orapred ODT

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.