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Orapred ODT

Treatment for Asthma -- Acute

BioMarin Announces U.S. FDA Acceptance of Orapred ODT Filing

Possible Approval in Mid-2006

NOVATO, Calif., October 19, 2005 -- BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) 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. The FDA will take action on the application, under the Prescription Drug User Fee Act (PDUFA), by June 1, 2006.

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 U.S. market.

Source: BioMarin

Posted: October 2005

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