April 6, 2023

• Compounding Safety Information: Quinacrine Hydrochloride

April 5, 2023

• Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance
• Draft Guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
• Draft Guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act
• FDA Drug Shortages
  • Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Calcium Acetate Oral Solution (New - Discontinuation)
  • Capecitabine Tablets (Updated - Currently in Shortage)
  • Chloramphenicol Sodium Succinate Injection (New - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Clonazepam Tablets (Updated - Currently in Shortage)
  • Ethinyl Estradiol / Norethindrone Acetate and Ferrous Fumarate Tablets (New - Discontinuation)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

April 4, 2023

• FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate 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)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

April 3, 2023

• FDA Drug Shortages
  • Glycopyrrolate Inhalational Solution (New - Discontinuation)
• SBIA Webinar: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
• SBIA Webinar: A Deep Dive: GDUFA III Scientific Meetings
• FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

March 31, 2023

• Final Guidance: Identification of Medicinal Products — Implementation and Use

March 30, 2023

• Competitive Generic Therapy Approvals (Updated)

March 29, 2023

• FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance

March 28, 2023

• Drugs@FDA Data Files (updated)

March 24, 2023

• FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
• FDA Drug Shortages
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Hydrocortisone Sodium Succinate Injection (New - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)

March 22, 2023

• FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

March 21, 2023

• Drugs@FDA Data Files (updated)
• Drug Trials Snapshot: PONVORY
• Biosimilar Basics for Patients (Updated)
• FDA Drug Shortages
  • Capecitabine Tablets (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Saxagliptin and Metformin Hydrochloride XR Tablets (New - Discontinuation)
  • Saxagliptin Tablets (New - Discontinuation)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

March 20, 2023

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

March 17, 2023

• Draft Guidance: Pharmacogenomic Data Submissions
• 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)
  • Dobutamine 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)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lorazepam 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)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Semaglutide (Ozempic) Injection (New - Currently in Shortage)
  • Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

March 16, 2023

• FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation
• FDA Drug Shortages
  • Albuterol Sulfate Inhalation Solution, 0.5% (Updated - Currently in Shortage)
  • Alclometasone Dipropionate Ointment (New - Discontinuation)
  • Betamethasone Dipropionate Cream (New - Discontinuation)
  • Prednicarbate Ointment (New - Discontinuation)
• Final Guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act 

March 15, 2023

• Competitive Generic Therapy Approvals (updated)
• Draft Guidance: Development of Local Anesthetic Drug Products With Prolonged Duration of Effect
• Draft Guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
• FDA Drug Shortages
  • Methotrexate Injection (New - Currently in Shortage)

March 14, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (New - Currently in Shortage)
  • Desmopressin Acetate Tablets (New - Discontinuation)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Methotrexate Injection (New - Currently in Shortage)
  • Remifentanil Injection (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
• Webinar: Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

March 13, 2023

• Drug Trial Snapshot: JEMPERLI
• Drug Trials Snapshots: QELBREE
• FDA Drug Shortages
  • Methotrexate Injection (New - Currently in Shortage)
• Notable Approvals | Drugs

March 10, 2023

• FDA Drug Shortages
  • Atropine Sulfate 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)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Gatifloxacin Ophthalmic Solution 0.5% (New - Discontinuation)
  • 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)
  • 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)
  • Oxytocin Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Valproate Sodium 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)

• March 9, 2023

  • FDA Drug Shortages
    • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)

  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