CDER New May 19, 2015

What's New on the FDA Drugs Site

May 18, 2015

• FDA Drug Shortages
  • Cefazolin Injection   (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride (Nubain) Injection   (Updated- Resolved)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Sodium Phosphate Injection   (Updated - Resolved)
  • Trace Elements   (Updated - Currently in Shortage)
  • Trypan Blue (Membraneblue)   (Updated - Resolved)
• Presentations
  • Applying the Breakthrough Criteria: Oncology, Neurology, Anti-Infective/Psychiatry/Hematology (PDF - 2MB)
  • Breakthrough Therapy Designation: An Analysis of the Past Two and a Half Years (PDF - 1MB)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)

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New and Generic Drug Approvals

May 15, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Ceftazidime In Dextrose Container	ceftazidime	Injectable;Injection	B Braun	Labeling Revision
Desvenlafaxine	desvenlafaxine	Tablet, Extended Release;Oral	Alembic Pharms Ltd	Labeling Revision
Xiaflex	collagenase clostridium histolyticum	Solution; Injection	Auxilium Pharms	Efficacy Supplement with Clinical Data to Support

 

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— Tuesday, May 19, 2015 — Add Comment