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A Georgia compounding pharmacy ran afoul of the FDA after losing the exemption from agency rules that is extended to compounders that limit their production to filling prescriptions for individual patients, the FDA said in a warning letter. Read More
Xarelto is primarily used to reduce the risk of stroke and systemic embolism, as well as to treat deep vein thrombosis and pulmonary embolism. Read More
CDER is currently conducting research to determine the effectiveness of limiting the risks in the major statement to the most severe, serious or actionable. Read More