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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

May 17, 2021

• COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry
• FDA Drug Shortages
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
• Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry

May 14, 2021

• FDA approves new treatment for adults with serious rare blood disease
• FDA Drug Shortages
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Desmopressin Acetate Nasal Spray (New - Currently in Shortage)
  • Desmopressin Acetate Nasal Spray (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydroxocobalamin Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Zinc Acetate Capsules (Updated - Currently in Shortage 
• 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)

May 12, 2021

• Patent Certifications and Suitability Petitions (updated)
• Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products (new)
• 2020 Office of Surveillance and Epidemiology Annual Report (new)

May 11, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
• Identification of Medicinal Products: Path to Global Implementation
• Guidance for Industry:
  • M9 Biopharmaceutics Classification System-Based Biowaivers
  • E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials
  • Q3D(R2) – Guideline for Elemental Impurities
  • S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals
  • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry
  • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
  • S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals
  • Qualified Infectious Disease Product Designation Questions and Answers
• Novo Nordisk Issues Voluntary Nationwide Recall of Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples Due to Improper Storage Temperature Conditions

May 7, 2021

• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Tablets (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
• June 9, 2021: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement

May 6, 2021

• DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)
• FDA Drug Shortages
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Triamcinolone Hexacetonide Injectable suspension (Updated - Currently in Shortage)

May 5, 2021

• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Capreomycin Injection (Updated - Discontinuation)
  • Triamcinolone Hexacetonide Injectable suspension (Updated - Currently in Shortage)
• FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer
• What's New in Regulatory Science (update)

May 4, 2021

• CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints (updated)
• Drugs@FDA Data Files (updated)
• From Our Perspective: Generic Drugs in the 21st Century: FDA’s Actions Create Transparency and Value for Complex Generic Product Development (new)
• Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan (updated)
• Patent Certifications and Suitability Petitions (updated)
• FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs (updated)
• FDA Drug Shortages
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Hydroxypropyl (Lacrisert) Cellulose Ophthalmic Insert (Updated - Currently in Shortage)
• Financial Transparency And Efficiency (updated)

May 3, 2021

• Written Requests Issued (updated)

April 30, 2021

• Over-The-Counter Monograph User Fee Program (OMUFA) (updated)

April 29, 2021

• Drug Safety Oversight Board (DSOB) Meeting March 31, 2021, Public Summary
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
• Public Notifications:
  • Tummy Tuck Max contains hidden drug ingredient
  • Enerup Premium contains hidden drug ingredient
  • ErectMax contains hidden drug ingredient
  • Vital Sex contains hidden drug ingredient
• Quarterly Inactive Ingredient Database (IID) Change Log (updated)

April 28, 2021

• GDUFA III Reauthorization Negotiation Session (updated)
• CDER Impact Stories: How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products
• FDA Drug Shortages
  • Atazanavir Capsules (New - Discontinuation)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)

April 27, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Olopatadine Hydrochloride Ophthalmic Solution (New - Discontinuation)
• FDA updates on hand sanitizers consumers should not use (update)
• Public Web Conference to Provide Progress Update on ICH E6 Guideline for Good Clinical Practice (May 18-19, 2021)

April 26, 2021

• CDER Impact Story: A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response
• FDA Drug Shortages
  • Acetazolamide Injection (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Atropine Sulfate Ophthalmic Ointment (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Azithromycin for Injection (New - Discontinuation)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydralazine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketoprofen Capsules (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Methadone Hydrochloride Injection (Updated - Currently in Shortage)
  • Methyldopa Tablets (Updated - Currently in Shortage)
  • Pindolol Tablets (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators

April 23, 2021

• FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
• FDA Drug Shortages
  • Acitretin Capsules (New - Discontinuation)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Fluticasone Inhalational Powder (New - Discontinuation)
  • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Interferon alfa-2b, Recombinant for Injection (New - Discontinuation)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Misoprostol Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Peginterferon alfa-2b Injection (New - Discontinuation)
  • Rosiglitasone Tablets (New - Discontinuation)
  • Salmeterol Xinafoate Inhalational Powder (New - Discontinuation)
  • Temozolomide Capsules (New - Discontinuation)
  • Valacyclovir Tablets (New - Discontinuation)

April 22, 2021

• Patent Certifications and Suitability Petitions (updated)
• FDA Drug Shortages
  • Etomidate Injection (Updated - Resolved)
• FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

April 21, 2021

• Virtual Workshop on 4/23: Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)
• FDA Drug Shortages
  • Hydroxocobalamin Injection (Updated - Currently in Shortage)
  • Nystatin and Triamcinolone Acetonide Topical Cream (New - Discontinuation)
  • Nystatin Topical Cream (New - Discontinuation)

April 20, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Hydroxocobalamin Injection (New - Currently in Shortage)
  • Protamine Sulfate Injection, USP (New - Currently in Shortage)
• GDUFA II Quarterly Performance

April 19, 2021

• FDA updates on hand sanitizers consumers should not use (update) 
• Outsourcing Facility Product Report for Hospitalized Patients with COVID-19 (update)