Industry News Roundup

FDA provides a draft guidance to formalize a request it made in a 2013 Drug Safety Communication for firms marketing OTCs containing acetaminophen to add label warnings about serious but rare, skin reactions, Stevens-Johnson Syndrome and toxic epidermal necrolysis. In its notice prepared for the Nov. 28 Federal Register announcing the availability of the draft, the agency says most of the requested labeling changes have been made by manufacturers for acetaminophen-containing OTCs approved through new drug applications or abbreviated NDAs. FDA says it also is asking for the label warnings on OTCs marketed under the Tentative Final Monograph for Internal Analgesic Antipyretic, and Antirheumatic Drug Products. In its August 2013 DSC, FDA said a review of medical literature and the agency’s adverse event reporting system revealed 107 cases from 1969 to 2012 that identified acetaminophen as a “probable” or “possible” case of the skin conditions, including 67 hospitalizations and 12 deaths Also see "In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill" - Pink Sheet, 5 August, 2013..