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

February 21, 2024

• Final Guidance: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

February 20, 2024

• Drugs@FDA Data Files (Updated)
• FDA Drug Shortages
  • Mannitol Injection (Updated - Resolved)
  • Remifentanil Hydrochloride Injection (Updated - Currently in Shortage)
• GDUFA Implementation Quarterly Meetings between FDA and Industry (Updated)

February 16, 2024

• FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer
• FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
• Drug Trials Snapshots: AGAMREE
• Drug Trials Snapshots: BRENZAVVY

February 15, 2024

• Drug Trials Snapshots: BIMZELX
• Drug Trials Snapshots: BEYFORTUS
• FDA Drug Shortages
  • Mepivacaine Hydrochloride Injection (Updated - Resolved)
• Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)

February 14, 2024

• Education Efforts to Help Increase Biosimilar Understanding and Acceptance
• FDA Drug Shortages
  • Rocuronium Bromide Injection (New - Currently in Shortage)

February 13, 2024

• Drugs@FDA Data Files (Updated)
• FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
• FDA Drug Shortages
  • Gentamicin Sulfate Injection (Discontinuation)
  • Morphine Sulfate Injection (Currently in Shortage)

February 12, 2024

• Draft Guidance: Use of Data Monitoring Committees in Clinical Trials

February 9, 2024

• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage)
  • Dextrose Monohydrate Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sterile Water Injection (Updated - Currently in Shortage)
• 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)                  
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)

February 8, 2004

• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)
  • Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)

February 7, 2024

• FDA and EMA launch Parallel Scientific Advice Pilot Program for Complex Generics

February 6, 2024

• Drugs@FDA Data Files (Updated)
• FDA Drug Shortages
  • Amoxapine Tablet (Updated - Currently in Shortage)
  • Azacitidine Injection (Updated - Currently in Shortage)
  • Carbamazepine Capsule, Extended Release (New - Discontinuation)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Clonazepam Tablet (Updated - Currently in Shortage)
  • Disopyramide Phosphate Capsule (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
  • Mesalamine Tablet, Delayed Release (New - Discontinuation)
  • Methotrexate Sodium Injection (Currently in Shortage)
  • Methotrexate Sodium Tablet (Currently in Shortage)
  • Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
  • Neomycin Sulfate Tablet (Updated - Currently in Shortage)
  • Sucralfate Tablet (Updated - Currently in Shortage)
  • Sulfasalazine Tablet (Updated - Currently in Shortage)

February 5, 2024

• Final Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act

February 2, 2024

• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)

February 1, 2024

• 美國食品藥物管理局增加了服用骨質疏鬆症藥物Prolia（狄諾塞麥）的晚期慢性腎病患者發生嚴重低鈣血症風險增加的黑框警告
• Drug Trials Snapshots: Vivjoa
• FDA Drug Shortages
  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Flurazepam Hydrochloride Capsule (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride Solution (Updated - Updated - Currently in Shortage)
  • Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
  • Sterile Water Injection (Updated - Currently in Shortage)
  • Sucralfate Tablet (Updated - Currently in Shortage)
  • Sulfasalazine Tablet (Updated - Currently in Shortage)

January 31, 2024

• La FDA ha añadido un recuadro de advertencia por el aumento del riesgo de hipocalcemia grave en pacientes con enfermedad renal crónica avanzada que reciben el medicamento para la osteoporosis Prolia (denosumab)
• FDA Drug Shortages
  • Hydroxypropyl Cellulose (1600000 Wamw) Insert (Updated - Currently in Shortage)
• FDA warns consumers of contaminated copycat eye drops

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)