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[DOI] [PubMed] [Google Scholar] 18.Gonzalez-Franquesa A, Stocks B, Borg ML, et al

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An earlier Phase II trial11 and two essentially identical Phase III trials (a study of at least moderate size that compares a new treatment with the current standard of care in patients), Gout 1 and Gout 2 have been presented.13 Data on shrinkage of tophi with this agent was also presented in 6/09.13 Cardiac events have occurred during the studies of Krystexxa, and the FDA reviewed them closely and concluded that they did not appear due to the medication

FDA released on Monday, come ahead of a July 23-24 meeting of its Pharmacy Compounding Advisory Committee, which will consider whether to add the peptides to the agency's list of bulk drug substances permitted for use in compounded medicines