CDER New: 9/29/2020

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 28, 2020

• FDA Drug Shortages
  • Ethambutol Hydrochloride Tablets (New - Discontinuation)
  • Guanidine Hydrochloride Tablets (New - Discontinuation)
  • Oxalaplatin Injection (New - Discontinuation)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
• Guidance for Industry
  • ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
  • Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
  • M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers

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 28, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved

September 27, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Combivent Respimat NDA #021747	Albuterol Sulfate; Ipratropium Bromide	Spray, Metered; Inhalation	SUPPL-20	Boehringer Ingelheim	Labeling	Approved
Kadcyla BLA #125427	Ado-Trastuzumab Emtansine	Vial; Single-Use	SUPPL-108	Genentech	Labeling	Approved

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
Xyrem NDA #021196	Sodium Oxybate	Solution; Oral	SUPPL-32	Jazz Pharms	Efficacy	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
Caduet NDA #021540	Amlodipine Besylate; Atorvastatin Calcium	Tablet; Oral	SUPPL-48	Pharmacia	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
Lovastatin ANDA #075451	Lovastatin	Tablet; Oral	SUPPL-25	Mylan	Labeling	Approved
Lovastatin ANDA #075935	Lovastatin	Tablet; Oral	SUPPL-8	Mylan	Labeling	Approved
Famotidine ANDA #075942	Famotidine	Injectable; Injection	SUPPL-12	Apotex Inc	Labeling	Approved
Famotidine Preservative Free (Pharmacy Bulk) ANDA #076322	Famotidine	Injectable; Injection	SUPPL-11	Apotex Inc	Labeling	Approved
Famotidine Preservative Free ANDA #076324	Famotidine	Injectable; Injection	SUPPL-11	Apotex Inc	Labeling	Approved
Fluvastatin Sodium ANDA #090595	Fluvastatin Sodium	Capsule; Oral	SUPPL-7	Mylan Pharms Inc	Labeling	Approved
Fluvastatin Sodium ANDA #090595	Fluvastatin Sodium	Capsule; Oral	SUPPL-7	Mylan Pharms Inc	Labeling	Approved
Campath BLA #103948	Alemtuzumab	Vial; Intravenous	SUPPL-5177	Genzyme	Labeling	Approved
Campath BLA #103948	Alemtuzumab	Vial; Intravenous	SUPPL-5177	Genzyme	Labeling	Approved
Campath BLA #103948	Alemtuzumab	Vial; Intravenous	SUPPL-5179	Genzyme	Labeling	Approved
Lemtrada BLA #103948	Alemtuzumab	Injectable; Injection	SUPPL-5177	Genzyme	Labeling	Approved
Lemtrada BLA #103948	Alemtuzumab	Injectable; Injection	SUPPL-5177	Genzyme	Labeling	Approved
Lemtrada BLA #103948	Alemtuzumab	Injectable; Injection	SUPPL-5179	Genzyme	Labeling	Approved
Nucala BLA #125526	Mepolizumab	Injectable; Subcutaneous Lyophilized Power	SUPPL-17	Glaxosmithkline Llc	Efficacy	Approved
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-86	Bristol Myers Squibb	Labeling	Approved
Liptruzet NDA #200153	Atorvastatin Calcium; Ezetimibe	Tablet; Oral	SUPPL-12	Merck Sharp Dohme	Labeling	Approved
Xeljanz NDA #203214	Tofacitinib Citrate	Tablet; Oral	SUPPL-26	Pf Prism Cv	Efficacy	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
Galafold NDA #208623	Migalastat Hydrochloride	Capsule; Oral	SUPPL-3	Amicus Theraps Us	Labeling	Approved
Galafold NDA #208623	Migalastat Hydrochloride	Capsule; Oral	SUPPL-3	Amicus Theraps Us	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
Fetroja NDA #209445	Cefiderocol Sulfate Tosylate	Powder; Intravenous	SUPPL-2	Shionogi Inc	Efficacy	Approved
Nikita NDA #209875	Pitavastatin Sodium	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Icatibant Acetate ANDA #210118	Icatibant Acetate	Injectable; Subcutaneous	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Icatibant Acetate ANDA #210118	Icatibant Acetate	Injectable; Subcutaneous	SUPPL-2	Teva Pharms Usa	Labeling	Approved
Icatibant Acetate ANDA #211021	Icatibant Acetate	Injectable; Subcutaneous	SUPPL-3	Jiangsu Hansoh Pharm	Labeling	Approved
Nucala BLA #761122	Mepolizumab	Injectable; Subcutaneous	SUPPL-5	Glaxosmithkline	Labeling	Approved