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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
July 5, 2022
- Drugs@FDA Data Files (updated)
- Guidance for Industry: Identifying Trading Partners Under the Drug Supply Chain Security Act
June 30, 2022
- Drug Safety Communication: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
June 29, 2022
- Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
- Guidance for Industry: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
- Patent Certifications and Suitability Petitions
June 28, 2022
- Drugs@FDA Data Files (updated)
- Remifentanil Injection (Currently in Shortage) (new)
- CDER Conversations (updated)
June 27, 2022
- FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma
- The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use (New)
June 24, 2022
- Guidance for Industry—Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics (Draft)
June 23, 2022
- Guidances for Industry
June 22, 2022
- FDA Drug Shortages
- Acetic Acid Otic Solution (New - Discontinuation)
- Ampicillin for Injection (New - Discontinuation)
- Carbamazepine Oral Suspension (New - Discontinuation)
- Doxycycline Hyclate Tablets (Updated - Discontinuation)
- Lindane Shampoo 1% (New - Discontinuation)
- Lorazepam Injection (Updated - Currently in Shortage)
- Rifapentine Tablets (Updated - Currently in Shortage)
June 21, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Doxycycline Hyclate Tablets (New - Discontinuation)
- Olopatadine Hydrochloride Nasal Spray (New - Discontinuation)
June 17, 2022
- FDA Drug Shortages
- Acetazolamide Injection (Updated - Resolved)
- Amino Acids (Updated - Currently in Shortage)
- SBIA Webinar: Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
- SBIA Webinar: Best Practices for Topical Generic Product Development and ANDA Submission
June 16, 2022
- Orange Book Data Files (compressed) (updated)
- Updated: List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
- Competitive Generic Therapy Approvals (updated)
- FDA Drug Shortages
- Rosuvastatin Calcium Tablets (New - Discontinuation)
June 15, 2022
- FDA Drug Shortages
- Diazepam Rectal Gel (New - Currently in Shortage)
June 14, 2022
- Draft Guidance for Industry: Q9(R1) Quality Risk Management
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Loxapine Capsules (Updated - Resolved)
- Sclerosol Intrapleural Aerosol (Updated - Discontinuation)
- Patent Certifications and Suitability Petitions (updated)
June 13, 2022
- Chinese version of Ukoniq DSC: 出于安全关切,FDA撤回对淋巴瘤药物Ukoniq厄布利塞 (乌帕利斯 umbrlisib) 的批准
June 10, 2022
- Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC): Key Themes and Future Directions from the January 2022 Public Workshop
- Orange Book
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride 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 50% Injection (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)
- Epinephrine Injection, 0.1 mg/mL (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)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ibutilide Fumarate 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 (New - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Metronidazole 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)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (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 (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
June 9, 2022
- FDA Drug Shortages
- Acetaminophen (Ofirmev) Injection (New - Discontinuation)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Cefotetan Disodium Injection (Updated - Discontinuation)
- Cetirizine Hydrochloride Solution (New - Discontinuation)
- Gentamicin and Prednisolone Acetate Ophthalmic Suspension (New - Discontinuation)
- Gentamicin Sulfate Solution (New - Discontinuation)
- Lactulose Solution (New - Discontinuation)
- Nebivolol Hydrochloride Tablets (New - Discontinuation)
- Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment (New - Discontinuation)
- Sulfacetamide Sodium Solution (New - Discontinuation)
June 8, 2022
- Competitive Generic Therapy Approvals (updated)
- FDA Drug Shortages
- Amino Acids (New - Currently in Shortage)
- Amino Acids (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection (Updated - Resolved)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
June 7, 2022
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español: La FDA retira la aprobación del medicamento para linfoma Ukoniq (umbralisib) debido a preocupaciones de seguridad
- Drugs@FDA Data Files (updated)
June 6, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
- Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
June 3, 2022
June 1, 2022
- FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
- FDA Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
- 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)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (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)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection (Updated - Currently in Shortage)
- Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
- Iohexol (Omnipaque) 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)
- Lipid Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (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)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
May 31, 2022
- Drugs@FDA Data Files (updated)
- FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma
- FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Resolved)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate 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)
- Diltiazem Hydrochloride 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)
- Furosemide Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine 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)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Rifampin 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 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Umbrasilib Tosylate Tablets (Updated - Discontinuation)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)