Alliant will begin marketing an orally disintegrating tablet version of BioMarin's asthma treatment Orapred (prednisolone) in August or September.

FDA approved the Orapred ODT NDA June 1 after a standard review. Orapred oral solution is prescribed mostly for acute asthma exacerbation in children. The solution was approved in 2000.

Orapred ODT, the first orally disintegrating tablet corticosteroid available in the U.S., provides a "taste-masked, non-refrigerated and convenient formulation of prednisolone," the companies said.

In March, BioMarin granted Alliant - a pediatric specialty pharmaceutical company based in Alpharetta, Ga. -North American licensing rights to the Orapred product line in a deal that includes a percentage of sales.

At the time, BioMarin CEO Jean-Jacques Bienaime said that the deal suits a change in the company's focus.

"Orapred no longer fits well with our core business of developing and commercializing novel products for serious genetic and metabolic diseases," Bienaime said. Alliant, however, is "currently focused exclusively on the pediatric market."

- Jonathan Block

Orapred Tablet Formulation Gets FDA Nod

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