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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
A Pennsylvania district court refused to certify a group of corporate and institutional drug purchasers as plaintiffs in a class-action antitrust suit against several drugmakers — saying the approximately two-dozen organizations in the class was relatively small and did not meet legal class-action requirements. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. 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