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Updated Monday through Friday

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Draft Guidance: Mpox: Development of Drugs and Biological Products; Guidance for Industry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)
Examining Ingredient Substitution in the Opioid Pharmaceutical Supply Chain: Findings from CDER’s Product Survey (updated)

January 12, 2023

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)

December 23, 2022

Drug Shortages
- New
  - Azithromycin for Suspension (Discontinuation) 12/22/2022
  - Azithromycin Tablets (Discontinuation) 12/22/2022
  - Ranolazine Extended-Release Tablets (Discontinuation) 12/22/2022
  - Difluprednate Ophthalmic Emulsion (Currently in Shortage) 12/21/2022
  - Chlorothiazide Oral Suspension (Currently in Shortage) 12/20/2022
  - Budesonide Inhalational Suspension (Discontinuation) 12/19/2022
- Update
  - Etomidate Injection (Currently in Shortage) 12/22/2022
  - Ibutilide Fumarate Injection (Currently in Shortage) 12/22/2022
  - Etomidate Injection (Currently in Shortage) 12/21/2022
  - Ketamine Injection (Currently in Shortage) 12/21/2022
  - Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage) 12/21/2022
  - Remifentanil Injection (Currently in Shortage) 12/21/2022
  - Rifampin Injection (Currently in Shortage) 12/21/2022
  - Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Currently in Shortage) 12/19/2022
  - Azacitidine for Injection (Currently in Shortage) 12/19/2022

December 21, 2022

Draft Guidance: Controlled Correspondence Related to Generic Drug Development
Draft Guidance: M11 Clinical Electronic Structured Harmonised Protocol
Draft Guidance: M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
Draft Guidance: M11 Template: Clinical Electronic Structured Harmonised Protocol

December 20, 2022

Drugs@FDA Data Files (updated)

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