CDER New July 20, 2015

What's New on the FDA Drugs Site

July 17, 2015

• Draft Guidance on Lubiprostone (PDF 107KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication (Spanish): LA FDA refuerza la advertencia que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) puedan causar ataques cardiacos o derrames cerebrales
• National Drug Code Directory
• Orange Book
  • Additions/Deletions for Prescription and OTC Drug Product Lists
  • Appendix A: Product Name Index (PDF - 131KB)
  • Appendix B: Product Name Sorted by Applicant (PDF - 506KB)
  • Appendix C: Uniform Terms (PDF - 57KB)
  • Approved Drug Product List - Orange Book: FR Notice Determination of Safety or Effectiveness List (PDF - 152KB)
  • Orange Book Data Files (compressed) (ZIP - 605KB)
  • Orange Book Current Cumulative Supplement (PDF - 1MB)
• Pediatric Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act(updated)