BIOMARIN FILES NEW DRUG APPLICATION FOR ORAPRED ODT

BioMarin Pharmaceutical announced that it has submitted a New Drug Application to FDA 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 utilizes proprietary oral disintegrating tablet technology to provide a taste-masked, nonrefrigerated and easy-to-administer formulation of prednisolone. There are currently no prednisolone oral disintegrating tablets on the market.