CDER New June 28, 2018

June 27, 2018

• Antibacterial Susceptibility Test Interpretive Criteria pages:
  • Amikacin – Injection Products
  • Amoxicillin – Oral Products
  • Ampicillin – Oral, Injection Products
  • Cefixime – Oral Products
  • Cefpodoxime proxetil - Oral Products
  • Ceftaroline fosamil - Injection Products
  • Cephalexin – Oral Products
  • Chloramphenicol Injection Products
  • Clindamycin – Oral, Injection Products
  • Daptomycin Injection Products
  • Dicloxacillin – Oral Products
  • Fosfomycin tromethamine – Oral Products
  • Gemifloxacin – Oral Products
  • Kanamycin – Injection Products
  • Linezolid Oral, Injection Products
  • Metronidazole Oral, Injection Products
  • Nitrofurantoin – Oral Products
  • Oritavancin diphosphate – Injection
  • Oxacillin – Injection Products
  • Penicillin V – Oral Products
  • Plazomicin – Injection
  • Spectinomycin - Injection Products
  • Telavancin – Injection Products
  • Trimethoprim hydrochloride – Oral Products
• CDER Warning Letters 2018 (updated)
• List of Determinations Including Written Request (updated)
• Pulmonary-Allergy Drugs Advisory Committee Roster (updated)
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)