CDER New July 17, 2017

What's New on the FDA Drugs Site

July 14, 2107

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Dexrazoxane Injection (New - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)  
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Phosphate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
• Most Recent Changes to the Inactive Ingredient Directory
• National Drug Code Directory
• Orange Book (updated)
  • June 2017: Additions and Deletions to the Drug Product List (PDF - 202KB)
  • Appendix A: Product Name Index (PDF - 167KB)
  • Appendix B: Product Name Sorted by Applicant (PDF - 394KB)
  • Appendix C: Uniform Terms (PDF - 24KB)
  • Orange Book Current Cumulative Supplement (PDF - 2.4MB) 
  • Orange Book Data Files (compressed) (ZIP - 638KB)
  • Orange Book Patent Listing Dispute List
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 86KB)
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse & Abuse (PDF - 352 KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• First Generic Drug Approvals (updated)

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New and Generic Drug Approvals

July 14, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Emsam NDA #021336	Selegiline	Film, Extended Release; Transdermal	SUPPL-14	Somerset	Labeling	Approved

July 13, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Aralen Hydrochloride NDA #006002	Chloroquine Hydrochloride	Injectable; Injection	SUPPL-44	Sanofi Aventis Us	Labeling	Approved
Aralen NDA #006002	Chloroquine Phosphate	Tablet; Oral	SUPPL-44	Sanofi Aventis Us	Labeling	Approved
Axiron NDA #022504	Testosterone	Solution, Metered; Transdermal	SUPPL-16	Eli Lilly and Co	Labeling	Approved
Femara NDA #020726	Letrozole	Tablet; Oral	SUPPL-33	Novartis Pharms	Labeling	Approved
Levofloxacin ANDA #076826	Levofloxacin	Solution/Drops; Ophthalmic	SUPPL-1	Watson Labs Teva	Labeling	Approved
Testosterone ANDA #205328	Testosterone	Solution; Topical	ORIG-1	Actavis Labs Ut Inc		Approved
Tremfya BLA #761061	Guselkumab	Injectable; Injection	ORIG-1	Janssen Biotech	Type 1 - New Molecular Entity	Approved
Zyvox NDA #021130	Linezolid	Tablet; Oral	SUPPL-34	Pharmacia and Upjohn	Labeling	Approved
Zyvox NDA #021130	Linezolid	Tablet; Oral	SUPPL-34	Pharmacia and Upjohn	Labeling	Approved
Zyvox NDA #021131	Linezolid	Solution; Iv (Infusion)	SUPPL-28	Pharmacia and Upjohn	Labeling	Approved
Zyvox NDA #021131	Linezolid	Solution; Iv (Infusion)	SUPPL-28	Pharmacia and Upjohn	Labeling	Approved
Zyvox NDA #021132	Linezolid	For Suspension; Oral	SUPPL-33	Pharmacia and Upjohn	Labeling	Approved
Zyvox NDA #021132	Linezolid	For Suspension; Oral	SUPPL-33	Pharmacia and Upjohn	Labeling	Approved

 

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— Monday, July 17, 2017 — Add Comment