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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

December 11, 2023

• What You Should Know about Eye Drops
• Drug Trials Snapshots: VABYSMO
• Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements

December 8, 2023

• Drug Trials Snapshots: XENOVIEW
• 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)

December 7, 2023

• Drug Trials Snapshots: BRIUMVI
• Drug Trials Snapshots: VTAMA
• FDA Drug Shortages
  • Omeprazole; Sodium Bicarbonate For Suspension (New - Discontinuation)
  • Omeprazole; Sodium Bicarbonate Suspension (New - Discontinuation)
  • Testosterone Gel, Metered (New - Discontinuation)

December 6, 2023

• Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
• Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2
• FDA Drug Shortages
  • Amoxapine Tablet (Updated - Currently in Shortage)
  • Amoxicillin Powder, For Suspension (Updated - Currently in Shortage)
  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
  • Atropine Sulfate Ointment (New - Discontinuation)
  • Capecitabine Tablet (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Clonazepam Tablet (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Isoniazid Tablet (Updated - Currently in Shortage)
  • Methamphetamine Hydrochloride Tablet (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Methotrexate Sodium Tablet (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
  • Nizatidine Capsule (Updated - Currently in Shortage)
  • Streptozocin Powder, For Solution (Updated - Currently in Shortage)
  • Sucralfate Tablet (Updated - Currently in Shortage)
  • Sulfasalazine Tablet (Updated - Currently in Shortage)

December 5, 2023

• Drugs@FDA Data Files (Updated)
• FDA Drug Topics: An Overview of FDA’s Project Facilitate Oncology Expanded Access Program - December 12, 2023
• A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs

December 4, 2023

• Drug Trials Snapshots: SUNLENCA

December 1, 2023

• Drug Trials Snapshots: ROLVEDON
• Drug Trials Snapshots: SPEVIGO
• FDA Drug Shortages
  • Sodium Chloride 0.9% Irrigation (Updated - Currently in Shortage)
  • Sterile Water Irrigant (Updated - Currently in Shortage)

November 30, 2023

• New “Q&A with FDA” Podcast: A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska - now offering CE!

November 29, 2023

• Spotlight on CDER Science
• Competitive Generic Therapy Approvals (updated)
• Drug Trials Snapshots: IMJUDO

November 28, 2023

• Drugs@FDA Data Files (Updated)
• FDA Drug Safety Communication: FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
• FDA Drug Shortages
  • Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
• Drug Trials Snapshots: PLUVICTO

November 27, 2023

• Drug Trials Snapshots: VOQUEZNA
• Drug Trials Snapshots: ADUHELM
• Drug Trial Snapshots: AMVUTTRA
• Drug Trials Snapshots: TECVAYLI
• FDA Drug Shortages
  • Alclometasone Dipropionate Cream (New - Discontinuation)
  • Dulaglutide Injection (Updated - Currently in Shortage)
  • Felbamate Oral Suspension (New - Discontinuation)
  • Nitroglycerin Injection (Updated - Currently in Shortage)

November 24, 2023

• Drug Trials Snapshot: DAXXIFY

November 22, 2023

• Final Guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

November 21, 2023

• Drugs@FDA Data Files (Updated)
• CDER Alert: FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks
• Guidance Snapshot Pilot (Updated)

November 15, 2023

• Competitive Generic Therapy Approvals (updated)
• Expanded Access to Clofazimine

November 14, 2023

• Drugs@FDA Data Files (Updated)
• FDA Drug Shortages
  • Sodium Acetate Injection (New - Currently in Shortage)

November 13, 2023

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

November 9, 2023

• FDA Drug Shortages
  • Cyclopentolate Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Cyclopentolate Hydrochloride, Phenylephrine Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Fluorescein Sodium Injection (Updated - Currently in Shortage)
  • Lorazepam Injection (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)

November 8, 2023

• FDA approves fruquintinib in refractory metastatic colorectal cancer
• FDA amends pembrolizumab’s gastric cancer indication
• Untitled Letters (updated)
• FDA Drug Shortages
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

November 7, 2023