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News from CDER

 December 14. FDA approves sapropterin (Kuvan) to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Questions and Answers

 December 13. The labeling for Exjade (deferasirox) has been changed to include information about postmarketing reports of hepatic failure, some with a fatal outcome. MedWatch Information

 December 12. FDA issues an FDA Alert and Information for Healthcare Professionals sheet for carbamazepine. Drug Information

 December 10. FDA's safety reviews of Prilosec and Nexium find no evidence of increased rates of cardiac events. FDA News

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Page Last Updated: December 14, 2007

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