Orapred ODT
Generic name: prednisolone sodium phosphate
Treatment for: Asthma, acute
BioMarin Files New Drug Application for Orapred ODT
NOVATO, Calif., August 1, 2005 -- BioMarin Pharmaceutical Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets), a new formulation of Orapred (prednisolone sodium phosphate oral solution). Prednisolone is commonly used to reduce inflammation seen in numerous medical conditions including asthma, arthritis and cancer.
"Orapred ODT holds the potential to provide individuals of all ages with a new formulation of prednisolone that is convenient and easy to administer," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We are committed to maximizing the value of our Orapred franchise and expect to have Orapred ODT on the market in mid-2006, pending regulatory approval."
Orapred ODT utilizes proprietary oral disintegrating tablet technology to provide a taste-masked, non-refrigerated and easy-to-administer formulation of prednisolone. There are currently no prednisolone oral disintegrating tablets on the market.
Posted: August 2005
Related articles
- Orapred ODT BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc. - Treatment for Asthma and other Inflammatory Conditions in Children - June 1, 2006
- BioMarin Announces U.S. FDA Acceptance of Orapred ODT Filing - October 19, 2005
Orapred ODT (prednisolone sodium phosphate) FDA Approval History
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