FDA Bioequivalence Study On Metoprolol Shows Emerging Generic Investigation Strategy

Outside research project launches after FDA does not find a safety signal in its internal investigation into generic versions of AstraZeneca’s Toprol XL.

FDA’s assessment of potential bioequivalence and therapeutic equivalence problems with generic extended-release metoprolol products shows that the agency appears to be settling into a pattern for investigating these kinds of concerns, but is not using a single fixed script each time.

“Therapeutic inefficacy and adverse events have been reported by physicians and patients switching from brand to generic metoprolol extended release products,” FDA said in a

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