March 8, 2023

• Drug Trials Snapshots: AZSTARYS
• FDA Drug Shortages
  • Aminocaproic Acid Oral Solution (New - Discontinuation)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)

March 7, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (New - Currently in Shortage)

March 6, 2023

• 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)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cytarabine 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)
  • 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)
  • 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)
  • 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 (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)
  • Pentostatin Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Currently in Shortage)
  • Rocuronium Bromide 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 (Updated - Currently in Shortage)
  • Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Sufentanil Citrate Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF

March 3, 2023

• FDA expands early breast cancer indication for abemaciclib with endocrine therapy
• Competitive Generic Therapy Approvals (Updated)
• From our perspective: FDA actions to continue to ensure the safety of the nation’s drug supply
• 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)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Capecitabine Tablets (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Neomycin Sulfate Tablets (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Zolmitriptan (Zomig) Tablets (New - Discontinuation)
  • Zolmitriptan (Zomig-ZMT) Orally Disintegrating Tablets (New - Discontinuation)

March 2, 2023

• FDA Drug Shortages
  • Alvimopan Capsules (New - Discontinuation)
  • Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment (New - Discontinuation)

March 1, 2023

• Draft Guidance: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
• Final Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
• FDA Drug Shortages
  • Albuterol Sulfate Inhalational Solution (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Cyclopentolate Ophthalmic Solution (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Erythromycin Ophthalmic Ointment (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Physostigmine Salicylate Injection (Updated - Currently in Shortage)
  • Rifampin Capsules (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sucralfate Tablets (Updated - Currently in Shortage)
  • Sufentanil Citrate Injection (Updated - Currently in Shortage)

February 28, 2023

• FDA approves first treatment for Friedreich’s ataxia
• Drugs@FDA Data Files (updated)

February 27, 2023

• FDA Drug Shortages
  • ​Rocuronium Bromide Injection (New - Currently in Shortage)

February 24, 2023

• Draft Guidance: Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment
• FDA Drug Shortages
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (New - Currently in Shortage)
  • Tirofiban Hydrochloride Injection (New - Discontinuation)

February 23, 2023

• FDA Drug Shortages
  • Liothyronine Sodium Injection (New - Discontinuation)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)

February 22, 2023

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection (New - Currently in Shortage)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (New - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

February 21, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Azacitidine for Injection (New - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Capecitabine Tablets (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (New - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Tirzepatide Injection (Updated - Currently in Shortage)
  • Tirzepatide Injection (New - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

February 17, 2023

• FDA approves first enzyme replacement therapy for rare alpha-mannosidosis
• FDA Drug Shortages
  • Albuterol Sulfate Inhalational Solution (Updated - Currently in Shortage)
  • Capecitabine Tablets (New - Currently in Shortage)
  • Clobazam Tablets (New - Discontinuation)
  • Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
  • Rocuronium Bromide Injection (New - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (New - Currently in Shortage)
  • Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)
• Draft Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

February 16, 2023

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • 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)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (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)
  • 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)
  • 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)
  • 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)
  • Sodium Acetate Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (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)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Sufentanil Citrate Injection (Updated - Currently in Shortage)

February 15, 2023

• Competitive Generic Therapy Approvals (Updated)
• FDA Drug Shortages
  • Rocuronium Bromide Injection (New - Currently in Shortage)

February 14, 2023

• Drugs@FDA Data Files (updated)
• ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements (updated)

February 13, 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)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Capecitabine Tablets (New - Currently in Shortage)
  • Chloroprocaine Hydrochloride 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)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Floxuridine for Injection (Updated - Resolved)
  • 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)
  • 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)
  • 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)
  • 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)

February 10, 2023

• 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)
• Notable Approval: FDA approves drug combination treatment for adults with asthma
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Capecitabine Tablets (Updated - Currently in Shortage)
  • Palifermin (Kepivance) Lyophilized Powder for Injection (New - Currently in Shortage)

February 9, 2023

• FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
• Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review

February 8, 2023

• Public Notification: Alfia Weight Loss Capsules contain hidden drug ingredient
• Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics
• FDA Drug Shortages
  • Fluoxetine Tablets (New - Discontinuation)
  • Paclitaxel Injection (protein-bound particles) (Updated - Resolved)