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news.BioMarin Pharmaceutical has submitted a new drug application to the FDA for a tablet formulation of its anti-inflammation drug Orapred, currently available only in its oral solution form.
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The active ingredient of Orapred, prednisolone, is commonly used to reduce inflammation seen in numerous medical conditions including asthma, arthritis and cancer.
The new formulation of Orapred, known as Orapred ODT, utilizes orally 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.
“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 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.”