January 30, 2023

• Draft Guidance: Acromegaly: Developing Drugs for Treatment

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• Draft Guidance: Mpox: Development of Drugs and Biological Products; Guidance for Industry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
  • 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)
    • Appendix A: Product Name Index
    • Appendix B: Product Name Sorted by Applicant
    • Appendix C: Uniform Terms
• 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)

December 27, 2022

• October 28, 2022 Meeting of the Oncologic Drugs Advisory Committee - Transcript (New)
• ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements (Update)
  • GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings: Video Recording (New)
• Impact story: Prescription drug promotion in online character space limited (CSL) communications (New)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Iomeprol Injection (Updated - Resolved)