CDER New July 7, 2017

What's New on the FDA Drugs Site

July 6, 2017

• Comprehensive Table of Contents Headings and Hierarchy
• Comprehensive Table of Contents Headings and Hierarchy
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: BAXDELA
• eCTD Submission Standards
• National Drug Code Directory
• Specifications for eCTD Validation Criteria
• Technical Rejection Criteria for Study Data
• Transmitting Electronic Submissions Using eCTD Specifications
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 6, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
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
Vimovo NDA #022511	Esomeprazole Magnesium; Naproxen	Tablet, Delayed Release; Oral	SUPPL-19	Horizon Pharma Usa	Efficacy	Approved

July 5, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amlodipine and Olmesartan Medoxomil ANDA #207807	Amlodipine Besylate; Olmesartan Medoxomil	Tablet; Oral	ORIG-1	Glenmark Pharms Ltd		Approved
Dexmethylphenidate Hydrochloride ANDA #202731	Dexmethylphenidate Hydrochloride	Capsule, Extended Release; Oral	ORIG-3	Teva Pharms Usa		Approved
Dexmethylphenidate Hydrochloride ANDA #203614	Dexmethylphenidate Hydrochloride	Capsule, Extended Release; Oral	ORIG-1	Impax Labs Inc		Approved
Omeprazole NDA #209400	Omeprazole	Tablet, Orally Disintegrating, Extended Release; Oral	ORIG-1	Dexcel Pharma	Type 8 - Partial Rx to OTC Switch	Approved
Prepidil NDA #019617	Dinoprostone	Gel; Endocervical	SUPPL-17	Pharmacia and Upjohn	Labeling	Approved
Promacta NDA #022291	Eltrombopag Olamine	Tablet; Oral	SUPPL-18	Novartis Pharms Corp	Labeling	Approved
Promacta NDA #207027	Eltrombopag Olamine	For Suspension; Oral	SUPPL-3	Novartis Pharms Corp	Labeling	Approved
Prostin E2 NDA #017810	Dinoprostone	Suppository; Vaginal	SUPPL-19	Pharmacia and Upjohn	Labeling	Approved
Taltz BLA #125521	Ixekizumab	Injectable; Injection	SUPPL-3	Eli Lilly and Co	Labeling	Approved

 

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— Friday, July 7, 2017 — Add Comment