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

August 7, 2023

• CDERLearn Training and Education (updated)

August 4, 2023

• PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR

August 3, 2023

• Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
• Drug Trials Snapshots: FEXINIDAZOLE
• Drug Trials Snapshots: NEXTSTELLIS
• Drug Trials Snapshots: ZEGALOGUE
• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Azacitidine for Injection (New - Discontinuation)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
  • Linezolid Tablets (New - Discontinuation)
  • Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)

August 2, 2023

• Draft Guidance for Industry: Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief
• FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
• FDA Drug Shortages
  • Leucovorin Calcium Injection (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride Extended Release Tablets (Updated - Currently in Shortage)
  • Tirzepatide Injection (Updated - Currently in Shortage)

August 1, 2023

• Drugs@FDA Data Files (updated)
• CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drug
• FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Discontinuation)
  • Diclofenac Sodium Topical Gel (New - Discontinuation)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Isoniazid Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Pramipexole Dihydrochloride Extended Release Tablets (New - Discontinuation)

July 31, 2023

• FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

July 28, 2023

• Conference/Workshop - Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
• CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Methotrexate Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)

July 27, 2023

• Competitive Generic Therapy Approvals (updated)
• Drug Trials Snapshots: QULIPTA
• FDA Drug Shortages
  • Indigotindisulfonate Sodium Injection (Updated - Currently in Shortage)

July 26, 2023

• Final Guidance: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
• Prescription Stimulant Medications
• FDA Drug Shortages
  • Methylphenidate Hydrochloride Extended Release Tablets (New - Currently in Shortage)

July 25, 2023

• Drugs@FDA Data Files (updated)

July 24, 2023

• Event - OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
• Event - Advancing Generic Drug Development: Translating Science to Approval 2023
• CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Fluorescein Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methotrexate Tablets (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

July 21, 2023

• Drug Trials Snapshots: LEQVIO
• FDA Drug Shortages
  • Beclomethasone Dipropionate Monohydrate Nasal Spray (New - Discontinuation)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
  • Methamphetamine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Methotrexate Tablets (New - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)

July 20, 2023

• Drug Trials Snapshots: ZYNLONTA
• FDA Drug Shortages
  • Furosemide Injection (Updated - Currently in Shortage)
  • Metronidazole Injection (Updated - Currently in Shortage)

July 19, 2023

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

July 18, 2023

• Drugs@FDA Data Files (updated)
• GDUFA Implementation Quarterly Meetings between FDA and Industry (updated)
• Competitive Generic Therapy Approvals
• Drug Trials Snapshots: SAPHNELO
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Lorazepam Injection (New - Discontinuation)

July 17, 2023

• FDA Drug Shortages
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
• Novel Drug Approvals for 2023 (updated)

July 14, 2023

• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsules (New - 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)
  • Appendix A: Product Name Index (updated)
  • Appendix B: Product Name Sorted by Applicant (updated)
  • Appendix C: Uniform Terms (updated)

July 13, 2023

• FDA Drug Shortages
  • Edetate Calcium Disodium Injection (New - Currently in Shortage)
  • Methotrexate Injection (Updated - Currently in Shortage)

July 12, 2023

• FDA Drug Shortages
  • Diazepam Rectal Gel (Updated - Currently in Shortage)
  • Flurazepam Hydrochloride Capsules (Updated - Currently in Shortage)
  • Methylprednisolone Acetate Injection (New - Currently in Shortage)
  • Rivaroxaban Oral Suspension (Updated - Resolved)

July 11, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Memantine Hydrochloride Extended Release Capsules (New - Discontinuation)
  • Memantine Hydrochloride Tablets (New - Discontinuation)
  • Sincalide (Kinevac) Lyophilized Powder for Injection (Updated - Resolved)
• SBIA Chronicles: Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
• Draft Guidance: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
• Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma (updated)

July 10, 2023

• Drug Trials Snapshot: TAVNEOS
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (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)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (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)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Metronidazole Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Penicillin G Benzathine Injectable Suspension (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
• List of Determinations Including Written Request (updated)