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FDA Bioequivalence Study On Metoprolol Shows Emerging Generic Investigation Strategy

 
• By Brenda Sandburg

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 notice

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• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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