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FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones

 
• By Elizabeth Crawford

FDA adds kidney stones to the list of potential signals of a serious risk for alli based on AER information gathered between July and October 2011. GSK, which is confident in the safety and efficacy of alli when used correctly, placed the only OTC weight-loss drug on the auction block last April, but needs a buyer.

An FDA investigation into whether adverse event reports of kidney stones by alli userscouldsignal a serious risk might hinder GlaxoSmithKline Consumer Healthcare LP’s ability to divest the OTC weight-loss drug.

GSK “remains fully confident” in the safety and efficacy of alli (orlistat 60 mg) when it is used correctly, a spokeswoman said

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More from United States

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• By Sarah Karlin-Smith

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Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

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• By Sue Sutter

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Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

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