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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
February 10, 2023
- Orange Book
- Notable Approval: FDA approves drug combination treatment for adults with asthma
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Capecitabine Tablets (Updated - Currently in Shortage)
- Palifermin (Kepivance) Lyophilized Powder for Injection (New - Currently in Shortage)
February 9, 2023
- FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
- Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review
February 8, 2023
- Public Notification: Alfia Weight Loss Capsules contain hidden drug ingredient
- Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics
- FDA Drug Shortages
- Fluoxetine Tablets (New - Discontinuation)
- Paclitaxel Injection (protein-bound particles) (Updated - Resolved)
February 7, 2023
- Drugs@FDA Data Files (updated)
- Public Notification: PrimeZen Black 6000 contains hidden drug ingredients
February 6, 2023
- FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) 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)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lorazepam Injection (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)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Pentostatin Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (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)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
February 3, 2023
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
- FDA Drug Shortages
- Lixisenatide (ADLYXIN) Injection (New - Discontinuation)
- Paliperidone (INVEGA) Extended Release Tablets (New - Discontinuation)
February 2, 2023
- From Our Perspective | CDER’s Continued Efforts to Widen Naloxone Access
- Public Notification: MANNERS Energy Boost contains hidden drug ingredient
February 1, 2023
- FDA Drug Shortages
- Ritonavir Oral Solution (New - Discontinuation)
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)