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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 23, 2022
- Drug Shortages
- New
- Azithromycin for Suspension (Discontinuation) 12/22/2022
- Azithromycin Tablets (Discontinuation) 12/22/2022
- Ranolazine Extended-Release Tablets (Discontinuation) 12/22/2022
- Difluprednate Ophthalmic Emulsion (Currently in Shortage) 12/21/2022
- Chlorothiazide Oral Suspension (Currently in Shortage) 12/20/2022
- Budesonide Inhalational Suspension (Discontinuation) 12/19/2022
- Update
- Etomidate Injection (Currently in Shortage) 12/22/2022
- Ibutilide Fumarate Injection (Currently in Shortage) 12/22/2022
- Etomidate Injection (Currently in Shortage) 12/21/2022
- Ketamine Injection (Currently in Shortage) 12/21/2022
- Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage) 12/21/2022
- Remifentanil Injection (Currently in Shortage) 12/21/2022
- Rifampin Injection (Currently in Shortage) 12/21/2022
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Currently in Shortage) 12/19/2022
- Azacitidine for Injection (Currently in Shortage) 12/19/2022
- New
December 21, 2022
- Draft Guidance: Controlled Correspondence Related to Generic Drug Development
- Draft Guidance: M11 Clinical Electronic Structured Harmonised Protocol
- Draft Guidance: M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
- Draft Guidance: M11 Template: Clinical Electronic Structured Harmonised Protocol
December 20, 2022
- Drugs@FDA Data Files (updated)
December 19, 2022
- Competitive Generic Therapy Approvals (updated)
- Oncology Burst: FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer
December 16, 2022
- Podcast: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
- Notable Approval: FDA approves imaging drug to help identify lung cancer lesions
- FDA Drug Shortages
- Fluvoxamine ER Capsules (Updated - Resolved)
- Spotlight on CDER: Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs
December 15, 2022
- Generic Drugs Program Monthly and Quarterly Activities Report
- FDA Drug Shortages
- Dulaglutide (Trulicity) Injection (New - Currently in Shortage)
- Tirzepatide Injection (New - Currently in Shortage)
- Guidance: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (updated)
December 14, 2022
- Guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (updated)
- Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry (updated)
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
December 13, 2022
- Drugs@FDA Data Files (updated)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated)
- Drug Trial Snapshot: PEPAXTO
- FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Epinephrine Injection, Auto-Injector (Updated - Resolved)
- 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)
- Hydromorphone Hydrochloride 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)
December 12, 2022
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine 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)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
December 9, 2022
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Methylphenidate Hydrochloride Extended Release Tablets (New - Discontinuation)
- Orange Book
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)