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Updated Monday through Friday

• CDER Launches New Accelerating Rare disease Cures (ARC) Program
• 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 30, 2022

• Competitive Generic Therapy Approvals (updated)

September 29, 2022

• The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
• FDA approves first treatment for prurigo nodularis

September 28, 2022

• FDA Drug Shortages
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 10% Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Efavirenz Capsules (New - Discontinuation)
  • Etomidate Injection (Updated - Resolved)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Ibutilide Fumarate Injection (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Remifentanil Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
     

September 27, 2022

• Drugs@FDA Data Files (updated)
• Guidance for Industry: Providing Over-the-Counter Monograph Submissions in Electronic Format

September 23, 2022

• FDA Drug Shortages
  • Oxytocin Injection (New - Currently in Shortage)

September 22, 2022

• FDA Drug Shortages
  • Vecuronium Bromide for Injection (Currently in Shortage)
• Guidance for Industry: Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry

September 21, 2022

• FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
• FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer
• FDA Drug Shortages
  • Febuxostat Tablets (New - Discontinuation)
• Guidance for Industry: How To Obtain a Covered Product Authorization

September 20, 2022

• Drugs@FDA Data Files (updated)
• FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

September 19, 2022

• FDA Drug Shortages
  • Continuous Renal Replacement Therapy (CRRT) Solutions (Updated - Resolved)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)

September 16, 2022

• FDA Drug Shortages
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
• Generic Drugs Program Activities Report - Monthly Performance (updated)

September 15, 2022

• Competitive Generic Therapy Approvals (updated)

September 14, 2022

• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Protamine Sulfate Injection (Updated - Currently in Shortage)
  • Remifentanil Injection (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Semaglutide (WEGOVY®) Injection (Updated - Currently in Shortage)

September 13, 2022

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Hyoscyamine Sulfate Injection (New - Discontinuation)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Remifentanil Injection (Updated - Currently in Shortage)

September 12, 2022

• Generic Competition and Drug Prices (updated)
• Report on ANDA Savings (PDF, 580 KB)
• Guidance: Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Draft)
• Guidance: Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products (Draft)
• FDA Drug Shortages
  • Adenosine Injection (New - Discontinuation)
  • Doxercalciferol Injection (New - Discontinuation)
  • Epoprostenol Sodium for Injection and Sterile Diluent for Epoprostenol Sodium for Injection (New - Discontinuation)
  • Methylprednisolone Tablets (New - Discontinuation)
  • Rifampin Capsules (New - Discontinuation)
  • Rifampin Capsules (Updated - Currently in Shortage)

September 9, 2022

• Drugs@FDA Data Files (updated)
• Orange Book
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Patent Certifications and Suitability Petitions (updated)
• FDA Drug Shortages
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Vandetanib Tablets (Updated - Currently in Shortage)

September 8, 2022

• CDER Statement: FDA draft guidance aims to improve consistency of labeling for nonprescription drugs
• FDA Drug Shortages
  • Hydrochlorothiazide and Spironolactone (Aldactazide) Tablets (New - Discontinuation)
  • Iopromide (Ultravist) Injection (Updated - Currently in Shortage)
  • Oxaliplatin Injection (New - Discontinuation)
  • Ropivacaine Hydrochloride Injection (Updated - Discontinuation)
  • Verapamil Hydrochloride Tablets (New - Discontinuation)
• Final Guidance: Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

September 7, 2022

• FDA Drug Shortages
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (New - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

September 6, 2022

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Dextrose 10% Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
  • Glyburide and Metformin Hydrochloride Tablets (New - Discontinuation)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
  • Nizatidine Capsules (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

September 2, 2022

• FDA approves durvalumab for locally advanced or metastatic biliary tract cancer.
• FDA Drug Shortages
  • Iodixanol Injection (Updated - Currently in Shortage)
  • Iohexol Injection (Updated - Currently in Shortage)

September 1, 2022

• CDER Statement: FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute

August 31, 2022

• SBIA Conference: FDA NanoDay Symposium 2022
• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)

August 30, 2022

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Fenoldopam Mesylate (Corlopam) Injection (New - Discontinuation)
  • Procainamide Hydrochloride Injection (New - Discontinuation)
  • Remifentanil Injection (Updated - Currently in Shortage)
  • Synercid Injection (New -Discontinuation)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)