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• Draft Guidance for Industry: Q9(R1) Quality Risk Management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
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• 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

• Conference: Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites

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)

May 27, 2022

• FDA Drug Shortages
  • Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
  • Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)

May 26, 2022

• Frequently Asked Questions on Benzene Contamination in Drugs
• FDA Drug Shortages
  • Iopromide (Ultravist) Injection (New - Currently in Shortage)
  • Varenicline Tartrate (Chantix) Tablets (Updated - Resolved)

May 25, 2022

• FDA Drug Shortages
  • Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
  • Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
• Final Guidance for Industry: Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide

May 24, 2022

• Draft Guidance for Industry: Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

May 23, 2022

• Impact Story: Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

May 20, 2022

• FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Cladribine Injection (New - Discontinuation)
  • Dexamethasone Sodium Phosphate 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)

May 19, 2022

• Drugs@FDA Data Files (updated)
• Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (updated)
• Draft Guidance for Industry: Risk Management Plans to Mitigate the Potential for Drug Shortages
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
• Patent Certifications and Suitability Petitions (updated)

May 18, 2022

• FDA Drug Shortages
  • Nedocromil Sodium Ophthalmic Solution (New - Discontinuation)
  • Umbrasilib Tosylate Tablets (New - Discontinuation)
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (final guidance)

May 17, 2022

• Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (final guidance)
• Competitive Generic Therapy Approvals (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Daptomycin Injection (New - Discontinuation)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

May 16, 2022

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lutetium Lu 177 Dotatate (LUTATHERA) Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision