CDER New March 29, 2017

What's New on the FDA Drugs Site

March 28, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Packages
  • KISQALI (ribociclib) Tablets
  • Siliq (brodalumab)
• FDA approves new eczema drug Dupixent (dupilumab)
• FDA approves Zejula (niraparib) for the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers
• FDA Drug Shortages
  • Risperidone Orally Disintegrating Tablets, USP (New - Discontinuation)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)