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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
January 9, 2023
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Azacitidine for Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Diflunisal Tablets (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)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine 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)
- Mannitol Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Neomycin Sulfate Tablets (Updated - Currently in Shortage)
- Nizatidine Capsules (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Somatropin (SAIZEN) Injection (Updated - Discontinuation)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
- Sucralfate Tablets (New - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
January 6, 2023
- FDA Drug Shortages
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Somatropin (SAIZEN) Injection (New - Discontinuation)
- Somatropin Injection (New - Currently in Shortage)
January 4, 2023
- FDA Drug Shortages
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% 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)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Final Guidance: Format and Content of a REMS Document Guidance for Industry
January 3, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Abacavir Sulfate (Ziagen) Tablets (New - Discontinuation)
- Abacavir Sulfate; Lamivudine (Epzicom) Tablets (New - Discontinuation)
- Abacavir Sulfate; Lamivudine; Zidovudine (Trizivir) Tablets (New - Discontinuation)
- Dolutegravir Sodium (Tivicay) Tablets (New - Discontinuation)
- Fosamprenavir Calcium (Lexiva) Oral Solution (New - Discontinuation)
- Fosamprenavir Calcium (Lexiva) Tablets (New - Discontinuation)
- Glyburide (GLYNASE) Tablets (New - Discontinuation)
- Indigotindisulfonate Sodium Injection (Updated - Currently in Shortage)
- Maraviroc (Selzentry) Tablets (New - Discontinuation)
- Upcoming Webinar: Overview: Clinical Pharmacology Considerations for Neonatal Studies
December 28, 2022
- FDA Drug Shortages
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
December 27, 2022
- October 28, 2022 Meeting of the Oncologic Drugs Advisory Committee - Transcript (New)
- ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements (Update)
- Impact story: Prescription drug promotion in online character space limited (CSL) communications (New)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Iomeprol Injection (Updated - Resolved)
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