Zdrowie i gospodarka · 25/01/2008
FDA Clears Path for Quetiapine Fumarate Tablets 150mg to be Approved via Abbreviated New Drug Applications
The Food and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all other legal and regulatory requirements are met.