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.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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