AstraZeneca’s Gout Drug Zurampic Clears FDA; Renal, CV Safety Trial Required
Label includes box warning on acute renal failure risk.
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The latest drug development news and highlights from our FDA Performance Tracker.
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.
Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.