CDER New August 17, 2015

What's New on the FDA Drugs Site

August 14, 2015

• CDER Conversation: Pediatric pain management options 
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:
  • Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry (PDF - 154KB)
  • Botanical Drug Development: Guidance for Industry (PDF - 228KB)
  • Rare Diseases: Common Issues in Drug Development Guidance for Industry (PDF - 306KB)
• National Drug Code Directory
• Orange Book (updated)
  
  • Additions/Deletions for Prescription and OTC Drug Product Lists
    
  • Orange Book Current Cumulative Supplement (PDF - 1MB)
    
  • Orange Book Data Files (compressed) (ZIP - 605KB)
    
• Suitability Petitions (updated)

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New and Generic Drug Approvals

August 13, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
An-Sulfur Colloid	technetium tc-99m sulfur colloid kit	Solution;Injection, Oral	Pharmalucence	Manufacturing Change or Addition
Imbruvica	ibrutinib	Capsule;Oral	Pharmacyclics Inc	Manufacturing Change or Addition
Noxafil	posaconazole	Suspension;Oral	Schering	Manufacturing Change or Addition
Oxycontin	oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Efficacy Supplement with Clinical Data to Support
Tretinoin	tretinoin	Gel;Topical	Spear Pharms Inc	Approval
Ximino	minocycline hydrochloride	Capsule, Extended Release;Oral	Sun Pharm Inds Ltd	Manufacturing Change or Addition

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— Monday, August 17, 2015 — Add Comment