Physicians should measure baseline, post-treatment levels of electrolytes, creatinine in patients directed to take more than 45 mL oral sodium phosphate within 24 hours "to avert serious electrolyte problems," according to FDA backgrounder posted on CDER Web site Oct. 12. Report discusses data gleaned from medical literature, AER and Drug Quality Reporting System databases, implicating bowel cleanser/laxative in serious electrolyte disturbances. FDA recently announced its intention to limit oral sodium phosphate packages to 45 mL or less (1"The Tan Sheet" Aug. 6, p. 8)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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