Home » Affymax, Takeda Anemia Drug OK’d, REMS, Postmarket Studies Needed
Affymax, Takeda Anemia Drug OK’d, REMS, Postmarket Studies Needed
The FDA granted approval to Affymax and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS). Omontys (peginesatide), an injectable erythropoiesis-stimulating agent (ESA), can be marketed to adult chronic kidney disease patients on dialysis, the FDA said Tuesday.
Washington Drug Letter
Washington Drug Letter
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