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
  • 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)

December 8, 2022

• Draft Guidance: Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations

December 7, 2022

• Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry (updated)
• FDA Drug Shortages
  • Fluorescein Injection (Updated - Resolved)

December 6, 2022

• Drugs@FDA Data Files (updated)
• Compounding Outsourcing Facilities Annual Study

December 5, 2022

• Drug Safety Communication: Comunicado de la FDA sobre la seguridad de medicamentos, La FDA investiga el riesgo de hipocalcemia grave en pacientes de diálisis que reciben el medicamento para la osteoporosis Prolia (denosumab)
• Drug Safety Communication: 美国食品和药物管理局药物安全通讯 美国食品和药物管理局正在调查接受骨质疏松症药物 Prolia（狄诺塞麦）的透析患者患有严重低血钙症的风险
• Final Guidance: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials

December 2, 2022

• Drug Trial Snapshot: AMONDYS 45
• Draft Guidance: Statistical Approaches to Establishing Bioequivalence
• Draft Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
• Accelerated Approval Program (New)
• FDA Drug Shortages
  • Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Technetium TC-99m Sodium Pertechnetate Generator (Updated - Currently in Shortage)

December 1, 2022

• FDA Drug Shortages
  • Cefazolin Injection (Updated - Currently in Shortage)

November 30, 2022

• FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
• Competitive Generic Therapy Approvals (Updated)
• FDA Drug Shortages
  • Argatroban Injection (New - Discontinuation)
  • Cefixime Oral Capsules (Updated - Currently in Shortage)
  • Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)

November 29, 2022

• Drugs@FDA Data Files (updated)

November 28, 2022

• FDA Drug Shortages
  • Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
  • Bacteriostatic Water for Injection (Updated - Currently in Shortage)
  • Belatacept (Nulojix) Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine 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 5% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (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)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
  • Pentostatin Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

November 23, 2022

• FDA Drug Shortages
  • Alprostadil (Muse) Suppository (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Paliperidone Extended Release Tablets (New - Discontinuation)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Technetium TC-99m Sodium Pertechnetate Generator (Updated - Currently in Shortage)

November 22, 2022

• Drug Trial Snapshot: EVKEEZA
• Drugs@FDA Data Files (updated)
• FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors
• Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

November 21, 2022

• FDA Drug Shortages
  • Collagenase Ointment (New - Currently in Shortage)
• Public Notifications
  • JACK’D Sexual Enhancement Capsules contain hidden drug ingredient
  • JACK’D Sexual Enhancement Liquid contains hidden drug ingredient
• Webcast: FDA’s Labeling Resources for Human Prescription Drugs

November 18, 2022

• FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)
• Guidance: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Floxuridine for Injection (Updated - Currently in Shortage)
  • Glucagon Injection (Updated - Discontinuation)
  • Iomeprol Injection (Updated - Currently in Shortage)
  • Oxytocin Injection (Updated - Currently in Shortage)
  • Valproate Sodium Injection (Updated - Currently in Shortage)

November 17, 2022

• Office of Regulatory Policy (updated)

November 16, 2022

• FDA Drug Shortages
  • Neomycin Sulfate Tablets (New - Currently in Shortage)