• 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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