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Home » Postmarket Trials, REMS Tied to Anemia Drug Approval
Postmarket Trials, REMS Tied to Anemia Drug Approval
April 18, 2012
The FDA granted approval to Affymax’s 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).