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Updated Monday through Friday

February 4. 2022

Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic

February 3, 2022

Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry
Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry
Population Pharmacokinetics: Guidance for Industry
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)
Competitive Generic Therapy Approvals (updated)
FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
Drug Safety Communication: FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bumetanide 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)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride 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)
- 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)
- Metronidazole Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Misoprostol Tablets (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)
- 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 Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)

February 2, 2022

FDA Drug Shortages
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Omeprazole and Sodium Bicarbonate Powder for Suspension (New - Discontinuation)
- Propafenone Hydrochloride Tablets (New - Discontinuation)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)

February 1, 2022

Drugs@FDA Data Files (updated)
Guidance Document: Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs

January 31, 2022

FDA Drug Shortages
- Doxycycline Capsules (New - Discontinuation)
- Sodium Bicarbonate Injection (New - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
FDA-EMA Parallel Scientific Advice (PSA) Program - Webinar
Advances in FDA's Drug Safety Programs
- Drug Safety Priorities 2021 Report
From Our Perspective: FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future

January 28, 2022

Activities Report of the Generic Drugs Program (FY 2021) – FDARA Title VIII Section 807 and 805 (Updated)
FDA Drug Shortages
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Vitamin A Palmitate (Aquasol A) Injection (Updated - Currently in Shortage)

January 27. 2022

Patent Certifications and Suitability-Petitions (updated)
Chinese language translation of FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain: FDA警告使用丁丙诺啡药物治疗鸦片类药物成瘾会使药物溶解在口中的引发障碍和疼痛等牙齿问题使用药物的益处高于风险
FDA Drug Shortages
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)

January 26. 2022

FDA Drug Shortages
- Cefazolin Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Lipid Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
Guidance for Industry:
- Good ANDA Submission Practices Guidance for Industry
- Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry
Manual of Policies and Procedures (MAPP) 5220.5 Rev. 1 Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications

January 25, 2022

January 24, 2022

FDA Drug Shortages
- Metronidazole Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (New - Currently in Shortage)

January 21, 2022

Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance (updated)
Guidance for Industry: Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH).
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español: La FDA advierte sobre problemas dentales con los medicamentos de buprenorfina de disolución oral para tratar el trastorno por consumo de opiáceos y el dolor
FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cefixime Oral Capsules (New - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine 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)
- 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)
- Hydroxocobalamin Injection (Updated - Resolved)
- 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)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Misoprostol Tablets (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)
- Propofol Injectable Emulsion (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 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)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)

January 20, 2022

Competitive Generic Therapy Approvals (updated)
FDA Drug Shortages
- Dicyclomine Hydrochloride Oral Capsules (New - Discontinuation)
- Dacarbazine Injection (Updated - Currently in Shortage)
Orange Book Annual Edition (PDF - 10MB) (updated)
Orange Book Preface (updated)

January 19, 2022

FDA Drug Shortages
- Dacarbazine Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection (New - Currently in Shortage)

January 18, 2022

Competitive Generic Therapy Approvals (updated)
Drugs@FDA Data Files (updated)
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)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine 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)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for 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)
- 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)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Rifampin Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride 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 Phosphates Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)

January 14, 2022

FDA Drug Shortages
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Lipid Injection (Updated - Currently in Shortage)
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 (updated)
- Appendix B: Product Name Sorted by Applicant (updated)
- Appendix C: Uniform Terms (updated)

January 13, 2022

FDA Drug Shortages
- Acetazolamide Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Digoxin Injection (Updated - Currently in Shortage)
- Enalaprilat Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) 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)
- Lorazepam Injection (Updated - Currently in Shortage)
- Metronidazole Injection (New - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)

January 12, 2022

January 11, 2022

Compounding Activities | COVID-19 (updated)
Drugs@FDA Data Files (updated)
FDA Drug Shortages
- Pindolol Tablets (Updated - Resolved)
- Rifampin Capsules (Updated - Currently in Shortage)

January 10, 2022

FDA Drug Shortages
- Pioglitazone Hydrochloride Tablets (New - Discontinuation)
Inspection/Enforcement Resources (updated)

January 7, 2022

Public Notification: Tawon Liar contains hidden drug ingredient (new)
Drug Shortages
- Updated
  - Paclitaxel Injection (protein-bound particles) (Currently in Shortage)
  - Rifampin Capsules (Currently in Shortage)

January 6, 2022

Report: Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF - 598 KB)
CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 (updated)
Drug Shortages
- Updated
  - Lipid Injection (Currently in Shortage)
  - Technetium Tc 99m Sulfur Colloid Injection (Currently in Shortage)
  - Vecuronium Bromide for Injection (Currently in Shortage)
Drug Shortages (posted 1/5/2022)
- New
  - Diazepam Oral Solution (Concentrate) (Discontinuation)
- Updated
  - Atropine Sulfate Injection (Currently in Shortage)
  - Bacteriostatic 0.9% Sodium Chloride Injection (Currently in Shortage)
  - Bumetanide Injection (Currently in Shortage)
  - Bupivacaine Hydrochloride and Epinephrine Injection (Currently in Shortage)
  - Bupivacaine Hydrochloride Injection (Currently in Shortage)
  - Cytarabine Injection (Currently in Shortage)
  - Dexmedetomidine Injection (Currently in Shortage)
  - Dobutamine Hydrochloride Injection (Currently in Shortage)
  - Dopamine Hydrochloride Injection (Currently in Shortage)
  - Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
  - Furosemide Injection (Currently in Shortage)
  - Gentamicin Sulfate Injection (Currently in Shortage)
  - Heparin Sodium and Sodium Chloride 0.9% Injection (Currently in Shortage)
  - Hydromorphone Hydrochloride Injection (Currently in Shortage)
  - Ketorolac Tromethamine Injection (Currently in Shortage)
  - Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
  - Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage)
  - Lorazepam Injection (Currently in Shortage)
  - Mannitol Injection (Currently in Shortage)
  - Mepivacaine Hydrochloride Injection (Currently in Shortage)
  - Midazolam Injection (Currently in Shortage)
  - Misoprostol Tablets (Currently in Shortage)
  - Morphine Sulfate Injection (Currently in Shortage)
  - Ondansetron Hydrochloride Injection (Currently in Shortage)
  - Potassium Acetate Injection (Currently in Shortage)
  - Propofol Injectable Emulsion (Currently in Shortage)
  - Ropivacaine Hydrochloride Injection (Currently in Shortage)
  - Sodium Bicarbonate Injection (Currently in Shortage)
  - Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
  - Sodium Chloride 23.4% Injection (Currently in Shortage)
  - Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
  - Sodium Phosphates Injection (Currently in Shortage)
  - Sterile Water for Injection (Currently in Shortage)
  - Sulfasalazine Tablets (Currently in Shortage)

January 5, 2022

Public Notification: Artri Ajo King contains hidden drug ingredient

January 4, 2022

Drugs@FDA Data Files (updated)