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The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More
ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug. Read More
The Federal Circuit upheld two Sanofi patents for its antiarrhythmic drug Multaq (dronedarone) — agreeing with Sanofi’s argument that the drug’s label, which is required to be similar for any generic versions, would ultimately direct physicians to violate the company’s patent on using Multaq to prevent abnormal heart rhythms. Read More
Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug. Read More