Home » Par’s Generic Ultram ER Approved by the FDA
Par’s Generic Ultram ER Approved by the FDA
Par Pharmaceutical won FDA approval and 180 days of
marketing exclusivity for a generic version of Ortho-McNeil’s pain-management drug Ultram
extended release (ER). The approval follows an August ruling by the U.S. District Court for the District of Delaware that two patents on Ultram ER (tramadol
HCl) were invalid, clearing the way for Par to market the generic versions.
Washington Drug Letter
Washington Drug Letter
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