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

January 30, 2024

• Public Notifications:
  • Arize contains hidden drug ingredient
  • Updated: Schwinnng contains hidden drug ingredient
  • Updated: Sustain® contains hidden drug ingredients
• Drug Trials Snapshots: REZLIDHIA
• Drugs@FDA Data Files (Updated)
• Chinese Drug Safety Communication: 美國食品藥物管理局對服用批准用於2型糖尿病和肥胖症的某種藥物的患者的自殺念頭或行為報告的持續評估更新 初步評估未提示因果關係
• Comunicado de seguridad de la FDA: Actualización sobre la evaluación en curso de la FDA de los informes de pensamientos o acciones suicidas en pacientes que toman cierto tipo de medicamentos aprobados para la diabetes tipo 2 y la obesidad
• FDA Drug Shortages
  • Erythromycin Ointment (New - Currently in Shortage)
  • Triazolam Tablet (New - Discontinuation)

January 29, 2024

• FDA revises letter of authorization for the emergency use authorization for Paxlovid
• Draft Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

January 26, 2024

• FDA Drug Shortages
  • I.V. Fat Emulsion (Updated - Resolved)
  • Zolpidem Tartrate Tablet, Extended Release (New - Discontinuation)

January 24, 2024

• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride Solution (New - Currently in Shortage)
  • Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
• Final Guidance: Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry

January 23, 2024

• Webinar: Expanding Generic Drug Access Through International Engagements
• FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
• Drugs@FDA Data Files (Updated)
• Drug Trials Snapshot: NEXOBRID
• FDA Drug Shortages
  • Capecitabine Tablet (Updated - Discontinuation)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Liraglutide Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)

January 22, 2024

• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)
• FDA Drug Shortages
  • Amoxicillin Powder, For Suspension (Updated - Currently in Shortage)
  • Conivaptan Hydrochloride Injection (Updated - Discontinuation)
  • Heparin Sodium Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)

January 19, 2024

• FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
• Drug Safety Communication: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
• FDA Drug Shortages
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

January 17, 2024

• CDERLearn Training and Education (updated)
• FDA announces shelf-life extension for naloxone nasal spray
• Q&A with FDA Podcast Series offering Continuing Education (CE) Credits
  • A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska
  • FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska
  • Navigating the World of Online Pharmacies with CDR Lysette Deshields
  • Expanded Access with Dr. Jacqueline Corrigan-Curay

January 16, 2024

• Drugs@FDA Data Files (Updated)
• Drug Trials Snapshot: POSLUMA
• FDA Drug Shortages
  • Penicillin G Benzathine Injection (Updated - Currently in Shortage)
• Recomendaciones actualizadas de etiquetado de la FDA para productos biosimilares y biosimilares intercambiables
• Food and Drug Omnibus Report Act (FDORA) of 2022

January 12, 2024

• FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer
• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsule (New - Currently in Shortage)

January 11, 2024

• Orange Book
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
    • Appendix A: Product Name Index (updated)
    • Appendix B: Product Name Sorted by Applicant (updated)
    • Appendix C: Uniform Terms (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)

• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsule (New - Currently in Shortage)
• Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
• Competitive Generic Therapy Approvals (updated)

January 10, 2024

• FDA Drug Shortages
  • Penicillin G Benzathine Injection (New - Currently in Shortage)
• La FDA advierte a los consumidores de que no utilicen Ozempic (semaglutida) falsificado encontrado en la cadena de suministro de medicamentos de los EE.UU
• Medicamentos que contienen semaglutida comercializados para la diabetes de tipo 2 o la pérdida de peso

January 9, 2024

• Drugs@FDA Data Files (Updated)
• Drug Trials Snapshots: XENPOZYME
• FDA Drug Shortages
  • Triamcinolone Acetonide Injection (Updated - Currently in Shortage)
  • Valproate Sodium Injection (Updated - Discontinuation)

January 8, 2024

• Drug Trials Snapshots: KRAZATI
• FDA Drug Shortages
  • Carboplatin Injection (New - Currently in Shortage)

January 2, 2024

• Drugs@FDA Data Files (Updated)
• Public Notifications:
  • ENDUREA contains hidden drug ingredients
  • ForeverMen contains hidden drug ingredient
  • Seraphim Z contains hidden drug ingredient

December 29, 2023

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