Office of Prescription Drug Promotion - Core Launch Review Process - 11/20/2020 - 11/20/2020 | FDA

Office of Prescription Drug Promotion - Core Launch Review Process - 11/20/2020 - 11/20/2020 | FDA

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

• October 14, 2020
  
  
  • Upcoming Webcast: Office of Prescription Drug Promotion - Core Launch Review Process
  • FDA Drug Shortages
    • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

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.

October 13, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Binosto NDA #202344	Alendronate Sodium	Tablet, Effervescent; Oral	SUPPL-15	Ascend Theraps Us	Labeling	Approved
Remifentanil Hydrochloride ANDA #210594	Remifentanil Hydrochloride	Injectable; Injection	ORIG-1	Navinta Llc		Approved
Wakix NDA #211150	Pitolisant Hydrochloride	Tablet; Oral	ORIG-2	Harmony	Efficacy	Approved
Tavaborole ANDA #211297	Tavaborole	Solution; Topical	ORIG-1	Encube		Approved

October 9, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lamictal NDA #020241	Lamotrigine	Tablet; Oral	SUPPL-58	Glaxosmithkline Llc	Labeling	Approved
Lamictal Cd NDA #020764	Lamotrigine	Tablet, Chewable; Oral	SUPPL-51	Glaxosmithkline Llc	Labeling	Approved
Tindamax NDA #021618	Tinidazole	Tablet; Oral	SUPPL-7	Mission Pharma	Labeling	Approved
Lamictal Xr NDA #022115	Lamotrigine	Tablet, Extended Release; Oral	SUPPL-24	Glaxosmithkline Llc	Labeling	Approved
Lamictal Odt NDA #022251	Lamotrigine	Tablet, Orally Disintegrating; Oral	SUPPL-22	Glaxosmithkline Llc	Labeling	Approved
Unasyn NDA #050608	Ampicillin Sodium; Sulbactam Sodium	Injectable; Injection	SUPPL-47	Pfizer	Labeling	Approved
Avastin BLA #125085	Bevacizumab	Vial; Intravenous	SUPPL-336	Genentech	Labeling	Approved
Levonorgestrel and Ethinyl Estradiol ANDA #207033	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral-28	ORIG-1	Accord Hlthcare		Approved
Baclofen ANDA #212378	Baclofen	Tablet; Oral	ORIG-1	Innogenix		Approved
Ultomiris BLA #761108	Ravulizumab-Cwvz	Injectable; Injection	SUPPL-5	Alexion Pharm	Efficacy	Approved