CDER New: 9/22/2020

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 21, 2020

• FDA Alerts of Perrigo's voluntary albuterol inhaler recall
• Cumulative 503B Reported Drugs used for hospitalized patients with COVID-19
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
• BeSafeRx: Your Source for Online Pharmacy Information (Update)
  • BeSafeRx: Resources for the Media
  • BeSafeRx: Frequently Asked Questions (FAQs)
  • BeSafeRx: Resources for Consumers
  • Locate a State-Licensed Online Pharmacy
  • About BeSafeRx (Update)
  • Considering an Online Pharmacy?
  • BeSafeRx: Resources for Health Professionals
• FDA Drug Shortages
  • Indinavir (CRIXIVAN) Capsules (New - Discontinuation)

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 18, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Seroquel NDA #020639	Quetiapine Fumarate	Tablet; Oral	SUPPL-70	Astrazeneca Pharms	Labeling	Approved
Invirase NDA #021785	Saquinavir Mesylate	Tablet; Oral	SUPPL-25	Hoffmann-La Roche	Labeling	Approved
Invirase NDA #021785	Saquinavir Mesylate	Tablet; Oral	SUPPL-25	Hoffmann-La Roche	Labeling	Approved
Seroquel Xr NDA #022047	Quetiapine Fumarate	Tablet, Extended Release; Oral	SUPPL-41	Astrazeneca	Labeling	Approved
Seroquel Xr NDA #022047	Quetiapine Fumarate	Tablet, Extended Release; Oral	SUPPL-44	Astrazeneca	Labeling	Approved
Cefobid NDA #050551	Cefoperazone Sodium	Injectable; Injection	SUPPL-46	Pfizer	Labeling	Approved
Ilaris BLA #125319	Canakinumab	Injectable; Subcutaneous	SUPPL-100	Novartis Pharms	Labeling	Approved
Yervoy BLA #125377	Ipilimumab	Injectable; Injection	SUPPL-112	Bristol Myers Squibb	Efficacy	Approved
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-84	Bristol Myers Squibb	Efficacy	Approved
Opdivo BLA #125554	Nivolumab	Injectable; Injection	SUPPL-85	Bristol Myers Squibb	Efficacy	Approved
Vinorelbine Tartrate ANDA #200148	Vinorelbine Tartrate	Injectable; Injection	SUPPL-6	Mylan Labs Ltd	Labeling	Approved
Armonair Digihaler NDA #208798	Fluticasone Propionate	Powder; Inhalation	SUPPL-7	Teva Pharm	Labeling	Approved
Armonair Respiclick NDA #208798	Fluticasone Propionate	Powder; Inhalation	SUPPL-7	Teva Pharm	Labeling	Approved
Mefenamic Acid ANDA #209209	Mefenamic Acid	Capsule; Oral	ORIG-1	Strides Pharma		Approved

September 17, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Budesonide ANDA #208851	Budesonide	Tablet, Extended Release; Oral	ORIG-1	Mylan		Approved
Desmopressin Acetate ANDA #210223	Desmopressin Acetate	Injectable; Injection	ORIG-1	Ubi		Approved
Yonsa NDA #210308	Abiraterone Acetate	Tablet; Oral	SUPPL-1	Sun Pharma Global	Labeling	Approved
Potassium Chloride ANDA #210395	Potassium Chloride	Tablet, Extended Release; Oral	ORIG-1	Zydus Pharms		Approved
Erythromycin Lactobionate ANDA #211086	Erythromycin Lactobionate	Injectable; Injection	ORIG-1	Exela Pharma		Approved
Potassium Chloride 0.15% In Sodium Chloride 0.45% ANDA #212347	Potassium Chloride; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved
Potassium Chloride 0.3% and Sodium Chloride 0.9% ANDA #212347	Potassium Chloride; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved