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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
December 8, 2022
- Draft Guidance: Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
December 7, 2022
- Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry (updated)
- FDA Drug Shortages
- Fluorescein Injection (Updated - Resolved)
December 6, 2022
December 5, 2022
- Drug Safety Communication: Comunicado de la FDA sobre la seguridad de medicamentos, La FDA investiga el riesgo de hipocalcemia grave en pacientes de diálisis que reciben el medicamento para la osteoporosis Prolia (denosumab)
- Drug Safety Communication: 美国食品和药物管理局药物安全通讯 美国食品和药物管理局正在调查接受骨质疏松症药物 Prolia(狄诺塞麦)的透析患者患有严重低血钙症的风险
- Final Guidance: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
December 2, 2022
- Drug Trial Snapshot: AMONDYS 45
- Draft Guidance: Statistical Approaches to Establishing Bioequivalence
- Draft Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
- Accelerated Approval Program (New)
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Technetium TC-99m Sodium Pertechnetate Generator (Updated - Currently in Shortage)
December 1, 2022
- FDA Drug Shortages
- Cefazolin Injection (Updated - Currently in Shortage)
November 30, 2022
- FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
- Competitive Generic Therapy Approvals (Updated)
- FDA Drug Shortages
- Argatroban Injection (New - Discontinuation)
- Cefixime Oral Capsules (Updated - Currently in Shortage)
- Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
November 29, 2022
- Drugs@FDA Data Files (updated)
November 28, 2022
- FDA Drug Shortages
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Belatacept (Nulojix) Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Pentostatin Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
November 23, 2022
- FDA Drug Shortages
- Alprostadil (Muse) Suppository (Updated - Currently in Shortage)
- Azacitidine for Injection (Updated - Currently in Shortage)
- Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Paliperidone Extended Release Tablets (New - Discontinuation)
- Rifampin Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Technetium TC-99m Sodium Pertechnetate Generator (Updated - Currently in Shortage)
November 22, 2022
- Drug Trial Snapshot: EVKEEZA
- Drugs@FDA Data Files (updated)
- FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors
- Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
November 21, 2022
- FDA Drug Shortages
- Collagenase Ointment (New - Currently in Shortage)
- Public Notifications
- Webcast: FDA’s Labeling Resources for Human Prescription Drugs
November 18, 2022
- FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)
- Guidance: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Floxuridine for Injection (Updated - Currently in Shortage)
- Glucagon Injection (Updated - Discontinuation)
- Iomeprol Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Currently in Shortage)
- Valproate Sodium Injection (Updated - Currently in Shortage)
November 17, 2022
- Office of Regulatory Policy (updated)
November 16, 2022
- FDA Drug Shortages
- Neomycin Sulfate Tablets (New - Currently in Shortage)
November 15, 2022
- Drugs@FDA Data Files (updated)
- Competitive Generic Therapy Approvals (Updated)
- FDA Drug Shortages
- Amino Acids (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cefazolin Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Methyldopa Tablets (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
November 14, 2022
- FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
- Drug Trials Snapshots: TEPMETKO
- Drug Trials Snapshots: UKONIQ
- Drug Trials Snapshots: UKONIQ
- FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients (updated)
November 10, 2022
- Public Notification: Sangter Natural Male Energy Supplement contains hidden drug ingredient
- Orange Book
- Draft Guidance: Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
- FDA Drug Shortages
- Cytarabine Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
November 9, 2022
- Generic Drugs Program Activities Report - Monthly Performance (updated)
- FDA Drug Shortages
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
November 8, 2022
- Drugs@FDA Data Files (updated)
- Draft Guidance: Sameness Evaluations in an ANDA — Active Ingredients
- FDA Drug Shortages
- Cytarabine Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Glucagon Injection (New - Discontinuation)
- Hydrochlorothiazide and Spironolactone (Aldactazide) Tablets (New - Discontinuation)
- Iomeprol Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
November 7, 2022
- Final Guidance: M10 Bioanalytical Method Validation and Study Sample Analysis