CDER New: 9/14/2020

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 11, 2020

• FDA Drug Shortages
  • Cefepime Injection (Updated - Currently in Shortage)
• Orange Book
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (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 11, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Infed NDA #017441	Iron Dextran	Injectable; Injection	SUPPL-178	Allergan	Labeling	Approved
Prevacid NDA #020406	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-90	Takeda Pharms Usa	Labeling	Approved
Venofer NDA #021135	Iron Sucrose	Injectable; Intravenous	SUPPL-36	Am Regent	Labeling	Approved
Prevacid NDA #021428	Lansoprazole	Tablet, Orally Disintegrating, Delayed Release; Oral	SUPPL-37	Takeda Pharms Usa	Labeling	Approved
Feraheme NDA #022180	Ferumoxytol	Solution; Intravenous	SUPPL-24	Amag Pharms Inc	Labeling	Approved
Dexilant NDA #022287	Dexlansoprazole	Capsule, Delayed Release; Oral	SUPPL-31	Takeda Pharms Usa	Labeling	Approved
Injectafer NDA #203565	Ferric Carboxymaltose	Injectable; Intravenous	SUPPL-13	Am Regent	Labeling	Approved
Monoferric NDA #208171	Ferric Derisomaltose	Solution; Intravenous	SUPPL-1	Pharmacosmos As	Labeling	Approved

September 10, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Digoxin ANDA #040282	Digoxin	Tablet; Oral	SUPPL-23	Mylan Pharms Inc	Labeling	Approved
Valacyclovir Hydrochloride ANDA #078656	Valacyclovir Hydrochloride	Tablet; Oral	SUPPL-3	Hikma	Labeling	Approved
Dalfampridine ANDA #206836	Dalfampridine	Tablet, Extended Release; Oral	SUPPL-1	Actavis Labs Fl Inc	Labeling	Approved
Dalfampridine ANDA #206836	Dalfampridine	Tablet, Extended Release; Oral	SUPPL-1	Actavis Labs Fl Inc	Labeling	Approved
Sorafenib ANDA #207012	Sorafenib	Tablet; Oral	ORIG-1	Mylan Pharms Inc		Approved
Apixaban ANDA #210053	Apixaban	Unknown	ORIG-1	Sigmapharm Labs Llc		Tentative Approval
Docetaxel ANDA #210072	Docetaxel	Injectable; Injection	SUPPL-5	Mylan Labs Ltd	Labeling	Approved
Docetaxel ANDA #210848	Docetaxel	Injectable; Injection	SUPPL-4	Mylan Labs Ltd	Labeling	Approved