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FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones

This article was originally published in The Tan Sheet

Executive Summary

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.

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Alli Labels In U.S. Add Seizure Advisory Similar To E.U. Change

GSK also recently posted to the alli brand website statements on why language was added to the Drug Facts panel for the orlistat 60 mg product. FDA contacted Glaxo in November 2013 requesting a supplement NDA for the label change, FDA’s Division of Nonprescription Clinical Evaluation said.

Alli Labels In U.S. Add Seizure Advisory Similar To E.U. Change

GSK also recently posted to the alli brand website statements on why language was added to the Drug Facts panel for the orlistat 60 mg product. FDA contacted Glaxo in November 2013 requesting a supplement NDA for the label change, FDA’s Division of Nonprescription Clinical Evaluation said.

Alli Recall Could Help Mitigate Reputation Damage In Face Of Tampering

GSK investigates tampering with its alli weight-loss drug and positions itself as a consumer advocate with a U.S. recall of the product. By showing it is “on the side of good,” the firm could actually emerge from the crisis with a stronger reputation, crisis management expert Gene Grabowski says.

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