CDER New: 9/18/2020

[CATEGORY]

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

September 17, 2020

• Manual of Policies and Procedures (MAPP) 4510.2 Rev.2 CDER CLEARANCE OF FDA-RELATED ARTICLES, SPEECHES, AND OTHER PUBLICATIONS  
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Q&A for Consumers | Hand Sanitizers and COVID-19 (updated)

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 17, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Yonsa NDA #210308	Abiraterone Acetate	Tablet; Oral	SUPPL-1	Sun Pharma Global	Labeling	Approved

September 16, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Noxafil NDA #022003	Posaconazole	Suspension; Oral	SUPPL-26	Schering	Labeling	Approved
Noxafil NDA #022003	Posaconazole	Suspension; Oral	SUPPL-26	Schering	Labeling	Approved
Noxafil NDA #205053	Posaconazole	Tablet, Delayed Release; Oral	SUPPL-10	Merck Sharp Dohme	Labeling	Approved
Noxafil NDA #205053	Posaconazole	Tablet, Delayed Release; Oral	SUPPL-10	Merck Sharp Dohme	Labeling	Approved
Propofol ANDA #205576	Propofol	Injectable; Injection	ORIG-1	Innopharma		Approved
Decitabine NDA #205582	Decitabine	Powder; Intravenous	SUPPL-15	Sun Pharma Global	Labeling	Approved
Decitabine NDA #205582	Decitabine	Powder; Intravenous	SUPPL-15	Sun Pharma Global	Labeling	Approved
Noxafil NDA #205596	Posaconazole	Solution; Intravenous	SUPPL-10	Merck Sharp Dohme	Labeling	Approved
Noxafil NDA #205596	Posaconazole	Solution; Intravenous	SUPPL-10	Merck Sharp Dohme	Labeling	Approved
Envarsus Xr NDA #206406	Tacrolimus	Tablet, Extended Release; Oral	SUPPL-8	Veloxis Pharms Inc	Labeling	Approved
Flecainide Acetate ANDA #210683	Flecainide Acetate	Tablet; Oral	ORIG-1	Beximco Pharms Usa		Approved