CDER New

What's New on the FDA Drugs Site

March 26, 2015

• Public Notification: Green Algae Combination by Crane Beauty contains hidden drug ingredient
• Assessing CDER's Drug Safety-Related Regulatory Science Needs and Identifying Priorities (PDF - 247KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication (Spanish): Harvoni o Sovaldi: La FDA advierte de una reducción grave de la frecuencia cardiaca cuando se usa el medicamento antiarrítmico amiodarona junto con tratamientos contra la hepatitis C que contienen sofosbuvir (Harvoni o Sovaldi), en combinación con otro fármaco antivírico de acción directa
• FDA Drug Safety Podcast: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)
• National Drug Code Directory
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)