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Glaxo Lotronex

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In response to "many letters" about the company's Nov. 28 withdrawal of irritable bowel syndrome drug alosetron, FDA has drafted a letter to consumers saying that it "is ready to work with Glaxo Wellcome, as with any sponsor, to develop risk management plans to ensure appropriate patient access to medically important, effective drugs." The Dec. 18 letter, signed by CDER Director Janet Woodcock, MD, is another attempt to explain FDA's risk management concept to the public. Glaxo maintains that it had no choice but to withdraw the drug in the face of what it calls FDA's overly restrictive risk management proposa
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