FDA actions in brief

FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.

FDA approved prednisolone orally disintegrating tablets (OrapredODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.

Ezetimibe (Zetia, Merck/Schering-Plough) was approved in combination with fenofibrate for the treatment of hyperlipidemia. Previously, the drug was approved as monotherapy or in combination with statins for patients with hyperlipidema whose response to diet and exercise alone was inadequate.