CDER New July 10, 2017

What's New on the FDA Drugs Site

July 7, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Endari (L-glutamine oral powder), a new treatment for sickle cell disease
• FDA Drug Shortages
  • Molindone Hydrochloride Tablets (New - Currently in Shortage)
• FDA Medication Guides Page (updated)
• First Generic Drug Approvals (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 7, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Endari NDA #208587	L-Glutamine	Powder; Oral	ORIG-1	Emmaus Medcl	Type 5 - New Formulation or New Manufacturer	Approved
Liquid E-Z-Paque NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Readi-Cat 2 NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Readi-Cat 2 Smoothies NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Reclast NDA #021817	Zoledronic Acid	Injectable; Iv (Infusion)	SUPPL-27	Novartis	Labeling	Approved

July 6, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Bivalirudin ANDA #204876	Bivalirudin	Injectable; Intravenous	ORIG-1	Apotex Inc		Approved
Morphine Sulfate ANDA #208809	Morphine Sulfate	Solution; Oral	ORIG-1	Hi-Tech Pharmacal		Approved
Pediatric Advil NDA #020812	Ibuprofen	Suspension/Drops; Oral	SUPPL-24	Pfizer	Labeling	Approved
Protonix Iv NDA #020988	Pantoprazole Sodium	Injectable; Iv (Infusion)	SUPPL-59	Wyeth Pharms Inc	Labeling	Approved
Protonix NDA #020987	Pantoprazole Sodium	Tablet, Delayed Release; Oral	SUPPL-53	Wyeth Pharms Inc	Labeling	Approved
Protonix NDA #022020	Pantoprazole Sodium	For Suspension, Delayed Release; Oral	SUPPL-15	Wyeth Pharms Inc	Labeling	Approved
Topotecan Hydrochloride ANDA #204406	Topotecan Hydrochloride	Solution; Intravenous	ORIG-1	Accord Hlthcare		Approved
Vimovo NDA #022511	Esomeprazole Magnesium; Naproxen	Tablet, Delayed Release; Oral	SUPPL-19	Horizon Pharma Usa	Efficacy	Approved

 

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— Monday, July 10, 2017 — Add Comment