BioMarin Pharmaceutical, Inc.

U.S. FDA accepts Orapred ODT NDA filing

Published in FDA Law Weekly, November 17th, 2005

BioMarin Pharmaceutical, Inc., (BMRN) announced 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 U.S. 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,...

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Source: FDA Law Weekly (2005-11-17)

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