June 13, 2023

• Drugs@FDA Data Files (updated)
• Online Opioid Summits (updated)
• Competitive Generic Therapy Approvals (updated)
• Drug Trials Snapshots: MOUNJARO
• FDA 更新警告以提高用於治療多動症 (ADHD) 和其他疾病的處方興奮劑的安全使用 (Chinese language version of "FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions")
• FDA Drug Shortages
  • Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
  • 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)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (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)
  • 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)
  • Hydrocortisone Sodium Succinate 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)
  • Methotrexate 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)
  • Penicillin G Benzathine Injectable Suspension (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 14.6% Injection (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)
  • Sufentanil Citrate Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
• List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated)

June 12, 2023

• FDA approves first treatment for pediatric functional constipation

June 9, 2023

• FDA Drug Shortages
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) 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)

June 8, 2023

• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment (Updated - Discontinuation)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Cyclopentolate Ophthalmic Solution (Updated - Currently in Shortage)
  • Desmopressin Acetate Nasal Spray (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 10% Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Mannitol 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 Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

June 7, 2023

• Drug Trials Snapshot: CIBINQO
• FDA Drug Shortages
  • Amoxicillin Oral Powder for Suspension (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)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Methotrexate Injection (Updated - Currently in Shortage)
  • Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Remifentanil Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)

June 6, 2023

• Drugs@FDA Data Files (updated)
• For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems
• Draft Guidance: E6(R3) GOOD CLINICAL PRACTICE (GCP)
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Amoxicillin Oral Powder for Suspension (New - 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)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Isoniazid Tablets (Updated - Currently in Shortage)
  • Methotrexate Injection (Updated - Currently in Shortage)
  • Montelukast Sodium Oral Granules (New - Discontinuation)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

June 5, 2023

• Final Guidance: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
• Final Guidance: Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
• FDA Drug Shortages
  • Cisplatin Injection (New - Currently in Shortage)
  • Fluticasone Propionate Inhalational Powder (New - Discontinuation)

June 1, 2023

• Draft Guidance: Migraine: Developing Drugs for Preventive Treatment
• Drug Trials Snapshot: PYRUKYND

May 31, 2023

• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Cytarabine 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)
  • Dextrose 50% 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)
  • Fludarabine Phosphate 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)
  • Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Viscous) Oral Topical Solution (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)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Methotrexate 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)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - 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)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

May 30, 2023

• Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss
• Drug Trials Snapshot: NEXVIAZYME
• Drugs@FDA Data Files (updated)

May 26, 2023

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

May 25, 2023

• Guidance Snapshot Pilot (Updated)
• Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products (updated)
• Final Guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (Updated)
• La FDA actualiza las advertencias para mejorar el uso seguro de los estimulantes recetados utilizados para tratar el TDAH y otras afecciones
• FDA Drug Shortages
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)

May 24, 2023

• Guidance Snapshot Pilot (Updated)
• Draft Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
• Final Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
• FDA Drug Shortages
  • 0.9% Sodium Chloride Irrigation (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • 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)
  • Parathyroid Hormone (Natpara) Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)

May 23, 2023

• Drugs@FDA Data Files (updated)
• Drug Trials Snapshot: VYVGART

May 22, 2023

• Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
• CDER Alert: G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging
• FDA Drug Shortages
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Ibrutinib Tablets (New - Discontinuation)

May 19, 2023

• FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
• FDA Drug Shortages
  • Doxercalciferol Capsules (New - Discontinuation)
  • Voriconazole Injection (New - Discontinuation)

May 18, 2023

• Drug Trials Snapshots: RYLAZE
• FDA Drug Shortages
  • Estramustine Phosphate Sodium Capsules (New - Discontinuation)
  • Lidocaine Hydrochloride (Viscous) Oral Topical Solution (New - Currently in Shortage)
• Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
• FDA approves first oral treatment for moderately to severely active Crohn’s disease

May 17, 2023

• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Chloramphenicol Sodium Succinate Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cisplatin 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)
  • Fludarabine Phosphate 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)
  • Isoniazid Tablets (New - 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)
  • Methotrexate 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)
• Drug Trials Snapshots: SCEMBLIX
• Drug Trials Snapshots: REZUROCK
• Draft Guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
• Draft Guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
• CDER Statement: FDA issues two draft guidances for industry to support the approval of pediatric drug products

May 16, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Bumetanide 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)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Enalaprilat Injection (Updated - Currently in Shortage)Back to Top
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Lorazepam 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)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Valproate Sodium Injection (Updated - Currently in Shortage)

May 15, 2023

• Competitive Generic Therapy Approvals (Updated)
• Drug Trials Snapshots: VOXZOGO
• FDA Drug Shortages
  • 0.9% Sodium Chloride Irrigation (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (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)
  • 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)
  • 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)
  • Methotrexate 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)
  • Pentostatin Injection (Updated - Resolved)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (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)
  • Somatropin Injection (Updated - Currently in Shortage)
  • Sterile Water for Irrigation (Updated - Currently in Shortage)