CDER New March 19, 2015

What's New on the FDA Drugs Site

March 18, 2015

• FDA Drug ShortagesList of Determinations Including Written Request  (updated)
  • Atropine Sulfate Injection   (Updated - Currently in Shortage)
  • Ceftazidime (Fortaz) Injection   (Updated - Resolved)
  • Dexamethasone Sodium Phosphate Injection   (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection   (Updated - Currently in Shortage)
  • Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Updated - Preservative Free)   (Currently in Shortage)
  • PEGINTRON (peginterferon alfa-2b) REDIPEN (New - Discontinuation) 
  • Sufentanil Citrate (Sufenta) Injection   (Updated - Currently in Shortage)
• Public Notification: Ultimate Boost contains hidden drug ingredient
• Public Notification: Xcel contains hidden drug ingredient
• Public Notification: Xcel Advanced contains hidden drug ingredient

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New and Generic Drug Approvals

March 17, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cholbam	cholic acid	Capsule;Oral	Asklepion Pharmaceuticals Llc	Approval
Perjeta	pertuzumab	Vial; Single-Use	Genentech	Efficacy Supplement with Clinical Data to Support
Signifor	pasireotide diaspartate	Solution;Subcutaneous	Novartis	Labeling Revision

 

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— Thursday, March 19, 2015 — Add Comment