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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

March 5, 2021

• Public Notifications
  • 2 Own The Knight Silver 4000 contains hidden drug ingredients
  • Rhino SE7EN² contains hidden drug ingredients
  • Stiff Rox contains hidden drug ingredients
  • Titanium 18K contains hidden drug ingredients
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Isoniazid Injection USP (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

March 4, 2021

• COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry

March 3, 2021

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Carbidopa, Levodopa and Entacapone, Tablets (New - Discontinuation)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)

March 2, 2021

• Drug Info Rounds Video - Medication Guides: Distribution Requirements for Health Care Professionals (March 2020)
• Phonetic and Orthographic Computer Analysis (POCA) Program (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)

March 1, 2021

• FDA Drug Shortages
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)

February 26, 2021

• FDA Drug Shortages
  • Succimer (Chemet) Capsules (New - Currently in Shortage)
• Public Notification: Vy & Tea contains hidden drug ingredient

February 25, 2021

• FDA Drug Shortages
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Belatacept (Nulojix) Lyophilized Powder for Injection (Updated - Currently in Shortage)
• Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)

February 24, 2021

• Public Notification: Alpha Male Plus contains hidden drug ingredient
• FDA Drug Shortages
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)

February 23, 2021

•  
• Drugs@FDA Data Files (updated)
• Manual of Policies and Procedures (MAPP) 4301.1 Rev 3 Center for Drug Evaluation and Research Medical Policy Council
• FDA Drug Shortages
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)

February 22, 2021

• COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
• Expanded Access INDs and Protocols (updated)
• Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)

February 19, 2021

• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

February 18, 2021

• FDA Drug Shortages
  • Bumetanide Tablets (New - Discontinuation)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Diclofenac Sodium Topical Solution (New - Discontinuation)

February 17, 2021

• FY 2021 Generic Drug Science and Research Initiatives Public Workshop
• Drug Trials Snapshot: CABENUVA
• FDA Drug Shortages
  • Hydroxyzine Pamoate Oral Capsules (Updated - Resolved)

February 16, 2021

• CDER Statement: FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia
• CDER Warning Letters (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
• (Updated)
  • Azacitidine for Injection (Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Currently in Shortage)
  • Cefotetan Disodium Injection (Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
  • Famotidine Injection (Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
  • Furosemide Injection, USP (Currently in Shortage)
  • Hydralazine Hydrochloride Injection, USP (Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Currently in Shortage)
  • Ketorolac Tromethamine Injection (Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage)
  • Morphine Sulfate Injection (Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Currently in Shortage)
  • Oxytocin Injection, USP Synthetic (Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
• (Updated 2/12/2021)
  • Atropine Sulfate Injection (Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Currently in Shortage)
  • Calcitriol Injection USP 1MCG /ML (Currently in Shortage)
  • Capreomycin Injection, USP (Currently in Shortage)
  • Cisatracurium Besylate Injection (Currently in Shortage)
  • Cyclopentolate Ophthalmic Solution (Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Currently in Shortage)
  • Dimercaprol (Bal in Oil) Injection USP (Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Currently in Shortage)
  • Dopamine Hydrochloride Injection (Currently in Shortage)
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Currently in Shortage)
  • Erythromycin Ophthalmic Ointment (Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Currently in Shortage)
  • Hydralazine Hydrochloride Injection, USP (Currently in Shortage)
  • Hydrocortisone Tablets, USP (Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Currently in Shortage)
  • Ketamine Injection (Currently in Shortage)
  • Ketorolac Tromethamine Injection (Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage)
  • Lorazepam Injection, USP (Currently in Shortage)
  • Midazolam Injection, USP (Currently in Shortage)
  • Misoprostol Tablets (Currently in Shortage)
  • Nalbuphine Hydrochloride Injection (Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Currently in Shortage)
  • Pantoprazole Sodium for Injection (Currently in Shortage)
  • Propofol Injectable Emulsion (Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Currently in Shortage)
  • Sulfasalazine Tablets (Currently in Shortage)

February 12, 2021

• FDA Drug Shortages

  New

  • Histreline Acetate Implant (2/11/2021 Currently in Shortage)

  Updated

  • Anagrelide Hydrochloride Capsules (2/10/2021 Currently in Shortage)
  • Azacitidine for Injection (2/10/2021 Currently in Shortage)
  • Cefepime Injection (2/10/2021 Resolved)
  • Cisatracurium Besylate Injection (2/11/2021 Currently in Shortage)
  • Dextrose 50% Injection (2/9/2021 Resolved)
  • Ketamine Injection (2/9/2021 Currently in Shortage)
  • Leuprolide Acetate Injection (2/11/2021 Currently in Shortage)
  • Pantoprazole Sodium for Injection (2/9/2021 Currently in Shortage)
  • Propofol Injectable Emulsion (2/9/2021 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)

February 11, 2021

• Office of Pharmaceutical Quality 2020 Annual Report
• Office of Generic Drugs 2020 Annual Report
• 2020 Drug Safety Priorities Report

February 10, 2021

• Drug Trials Snapshot: LUPKYNIS
• CDER’s Work to Meet User Fee Goals During the Pandemic
• CDER Warning Letters 2021 (updated)
• Comunicaciones de la FDA sobre la seguridad de los medicamentos en español: Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib)
• Drug Shortages: Non-Compliance With Notification Requirement (updated)
• Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program (updated)

February 9, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)

February 8, 2021

• Drug Trials Snapshot: VERQUVO
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Ceftazidime and Avibactam (AVYCAZ®) for Injection, 2 grams/0.5 grams (Updated - Currently in Shortage)

February 5, 2021

• FDA Drug Shortages
  • Acetazolamide Injection (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Enalaprilat Injection, USP (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Methyldopa Tablets (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Promethazine (Phenergan) Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Valproate Sodium Injection, USP (Updated - Currently in Shortage)
  • Zinc Acetate Capsules (Updated - Currently in Shortage)
• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
• GDUFA Reauthorization Sessions (updated)