CDER New: 9/15/2020

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 14, 2020

• Guidance for Industry: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
• FDA Drug Shortages
  • Tacrolimus Capsules (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.

September 13, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Botox BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5317	Allergan	Labeling	Approved
Botox Cosmetic BLA #103000	Onabotulinumtoxina	Vial; Single-Use	SUPPL-5317	Allergan	Labeling	Approved

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
Ceftriaxone ANDA #065204	Ceftriaxone Sodium	Injectable; Injection	SUPPL-26	Sandoz Inc	Labeling	Approved
Injectafer NDA #203565	Ferric Carboxymaltose	Injectable; Intravenous	SUPPL-13	Am Regent	Labeling	Approved
Iloperidone ANDA #207231	Iloperidone	Tablet; Oral	SUPPL-2	Inventia	Labeling	Approved
Monoferric NDA #208171	Ferric Derisomaltose	Solution; Intravenous	SUPPL-1	Pharmacosmos As	Labeling	Approved
Icosapent Ethyl ANDA #209525	Icosapent Ethyl	Capsule; Oral	ORIG-1	Teva Pharms Usa		Approved
Timolol Maleate ANDA #212291	Timolol Maleate	Solution/Drops; Ophthalmic	ORIG-1	Akorn Inc		Approved
Calcipotriene and Bethamethasone Dipropionate ANDA #212367	Betamethasone Dipropionate; Calcipotriene	Suspension; Topical	ORIG-1	Perrigo Uk Finco		Approved
Cetirizine Hydrochloride ANDA #213557	Cetirizine Hydrochloride	Tablet, Orally Disintegrating; Oral	ORIG-1	Aurobindo Pharma Ltd		Approved