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Orapred ODT FDA Approval History

FDA Approved: Yes (First approved June 1, 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 timeline 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

Further information

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