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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 31, 2023
- Draft Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- Drugs@FDA Data Files (updated)
- Draft Guidance: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
January 30, 2023
- Competitive Generic Therapy Approvals (updated)
- Draft Guidance: Acromegaly: Developing Drugs for Treatment
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
January 26, 2023
- FDA announces Evusheld is not currently authorized for emergency use in the U.S.
- FDA Drug Shortages
- Azithromycin (Azasite) Ophthalmic Solution 1% (Updated - Currently in Shortage)
- Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
January 25, 2023
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Ibuprofen and Famotidine Tablets (New - Discontinuation)
January 24, 2023
- Drugs@FDA Data Files (updated)
January 23, 2023
- Final Guidance: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research (Updated)
January 20, 2023
- Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever
- FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems
- New Safety Measures Announced for Extended-release and Long-acting Opioids (updated)
- FDA Drug Shortages
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
January 19, 2023
- Competitive Generic Therapy Approvals (updated)
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)
- Draft Guidance: Mpox: Development of Drugs and Biological Products; Guidance for Industry
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Quinapril Hydrochloride Tablets (New - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Rifampin Capsules (Updated - Currently in Shortage)
January 18, 2023
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Technetium TC-99m Sodium Pertechnetate Generator (Updated - Resolved)
January 17, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- FDA Rationale for Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.
- FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales
January 13, 2023
- FDA Drug Shortages
- Ranolazine Extended-Release Tablets (Updated - Discontinuation)
- Orange Book
- Examining Ingredient Substitution in the Opioid Pharmaceutical Supply Chain: Findings from CDER’s Product Survey (updated)
January 12, 2023
- CDER Conversation: Biosimilar User Fee Amendments Latest Implementation: BsUFA III
Draft Guidance: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format; Guidance for Industry - FDA Drug Shortages
- Technetium Tc99m Succimer Injection (DMSA) (Updated - Resolved)
January 10, 2023
- Notable Approval: FDA approves drug combination treatment for adults with asthma
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Moxetumomab pasudotox-tdfk (Lumoxiti) Injection (New - Discontinuation)
- Testosterone Transdermal System (Film, Extended Release) (New - Discontinuation)
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)