CDER New: 9/28/2020

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 25, 2020

• FDA Drug Shortages
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • 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.

September 25, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Zocor NDA #019766	Simvastatin	Tablet; Oral	SUPPL-101	Msd Merck Co	Labeling	Approved
Pravachol NDA #019898	Pravastatin Sodium	Tablet; Oral	SUPPL-69	Bristol Myers Squibb	Labeling	Approved
Lipitor NDA #020702	Atorvastatin Calcium	Tablet; Oral	SUPPL-78	Upjohn	Labeling	Approved
Lescol Xl NDA #021192	Fluvastatin Sodium	Tablet, Extended Release; Oral	SUPPL-31	Novartis	Labeling	Approved
Altoprev NDA #021316	Lovastatin	Tablet, Extended Release; Oral	SUPPL-36	Covis Pharma Bv	Labeling	Approved
Crestor NDA #021366	Rosuvastatin Calcium	Tablet; Oral	SUPPL-42	Ipr	Labeling	Approved
Vytorin NDA #021687	Ezetimibe; Simvastatin	Tablet; Oral	SUPPL-63	Msd Intl	Labeling	Approved
Livalo NDA #022363	Pitavastatin Calcium	Tablet; Oral	SUPPL-18	Kowa Co	Labeling	Approved
Nucala BLA #125526	Mepolizumab	Injectable; Subcutaneous Lyophilized Power	SUPPL-17	Glaxosmithkline Llc	Efficacy	Approved
Liptruzet NDA #200153	Atorvastatin Calcium; Ezetimibe	Tablet; Oral	SUPPL-12	Merck Sharp Dohme	Labeling	Approved
Flolipid NDA #206679	Simvastatin	Suspension; Oral	SUPPL-3	Tcg Fluent Pharma	Labeling	Approved
Zypitamag NDA #208379	Pitavastatin Magnesium	Tablet; Oral	SUPPL-4	Medicure	Labeling	Approved
Ezallor Sprinkle NDA #208647	Rosuvastatin Calcium	Capsule; Oral	SUPPL-4	Sun Pharma Global	Labeling	Approved
Ezallor Sprinkle NDA #208647	Rosuvastatin Calcium	Capsule; Oral	SUPPL-4	Sun Pharma Global	Labeling	Approved
Nikita NDA #209875	Pitavastatin Sodium	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Nucala BLA #761122	Mepolizumab	Injectable; Subcutaneous	SUPPL-5	Glaxosmithkline	Labeling	Approved

September 24, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Arthrotec NDA #020607	Diclofenac Sodium; Misoprostol	Tablet, Delayed Release; Oral	SUPPL-36	Pfizer	Labeling	Approved
Arthrotec NDA #020607	Diclofenac Sodium; Misoprostol	Tablet, Delayed Release; Oral	SUPPL-36	Pfizer	Labeling	Approved
Arthrotec NDA #020607	Diclofenac Sodium; Misoprostol	Tablet, Delayed Release; Oral	SUPPL-36	Pfizer	Labeling	Approved
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-20	Organon Usa Inc	Labeling	Approved
Implanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-20	Organon Usa Inc	Labeling	Approved
Nexplanon NDA #021529	Etonogestrel	Implant; Implantation	SUPPL-19	Organon Usa Inc	Labeling	Approved
Reyataz NDA #021567	Atazanavir Sulfate	Capsule; Oral	SUPPL-44	Bristol Myers Squibb	Labeling	Approved
Reyataz NDA #021567	Atazanavir Sulfate	Capsule; Oral	SUPPL-44	Bristol Myers Squibb	Labeling	Approved
Revlimid NDA #021880	Lenalidomide	Capsule; Oral	SUPPL-54	Celgene	REMS	Approved
Benlysta BLA #125370	Belimumab	Injectable; Injection	SUPPL-71	Human Genome Sciences Inc.	Efficacy	Approved
Stivarga NDA #203085	Regorafenib	Tablet; Oral	SUPPL-12	Bayer Hlthcare	Labeling	Approved
Kalydeco NDA #203188	Ivacaftor	Tablet; Oral	SUPPL-33	Vertex Pharms	Efficacy	Approved
Reyataz NDA #206352	Atazanavir Sulfate	Powder; Oral	SUPPL-8	Bristol Myers Squibb	Labeling	Approved
Reyataz NDA #206352	Atazanavir Sulfate	Powder; Oral	SUPPL-8	Bristol Myers Squibb	Labeling	Approved
Kalydeco NDA #207925	Ivacaftor	Granule; Oral	SUPPL-11	Vertex Pharms Inc	Efficacy	Approved
Alaway ANDA #208158	Ketotifen Fumarate	Solution/Drops; Ophthalmic	ORIG-1	Bausch		Approved
Dimethyl Fumarate ANDA #210305	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Cipla		Approved
Dimethyl Fumarate ANDA #210402	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Amneal		Approved
Dimethyl Fumarate ANDA #210440	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Alkem Labs Ltd		Approved
Dimethyl Fumarate ANDA #210460	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Msn		Approved
Dimethyl Fumarate ANDA #210499	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Accord Hlthcare		Approved
Dimethyl Fumarate ANDA #210500	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Hetero Labs Ltd Iii		Approved
Dimethyl Fumarate ANDA #210538	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Zydus Pharms		Approved
Naproxen Sodium and Diphenhydramine Hydrochloride ANDA #213663	Diphenhydramine Hydrochloride; Naproxen Sodium	Tablet; Oral	ORIG-1	Granules India Ltd		Approved
Cyanocobalamin ANDA #214390	Cyanocobalamin	Injectable; Injection	ORIG-1	Gland Pharma Ltd		Approved