Novartis gets FDA panel nod for transplant drug – A U.S. advisory panel recommended approval of a Novartis AG drug to prevent rejection of transplanted kidneys, a Food and Drug Administration spokeswoman said on Monday. The panel voted 11-1 to urge FDA clearance of the drug, everolimus, for patients who have undergone kidney transplants, FDA spokeswoman Karen Mahoney said. The agency usually approves drugs that win support from advisory panels…more
New liquid sustained-release formulation coming to market – While in general, the availability of once-daily oral Clonidine will be welcomed by patients using the drug for an extended period, the Food and Drug Administration’s (FDA) decision has wider implications. This is because, for the first time, a delivery platform combining 24-hour SR technology with the ultra accurate adjustments available to liquid formulations has been granted marketing approval, which, as Tris’ head of R&D, Yu-Hsing Tu, explained, offers significant dosing advantages formulations …more
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