April 28, 2023

• FDA Drug Shortages
  • 0.9% Sodium Chloride Irrigation (New - Currently in Shortage)
  • Carboplatin Injection (New - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Prazosin Hydrochloride Capsules (New - Discontinuation)
  • Sterile Water for Irrigation (New - Currently in Shortage)

April 26, 2023

• FDA Drug Shortages
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine 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)
  • Nicotrol (Nicotine) Inhaler (New - Discontinuation)
  • Penicillin G Benzathine Injectable Suspension (New - Currently in Shortage)
  • Rocuronium Bromide Injection ((Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection ((Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags ((Updated - Currently in Shortage)
• La FDA actualiza la información sobre la prescripción de todos los analgésicos opioides para ofrecer orientaciones adicionales sobre su uso seguro

April 25, 2023

• Drugs@FDA Data Files (updated)
• FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
• Patent Certifications and Suitability Petitions (UPDATED)

April 24, 2023

• FDA Drug Shortages
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
• Regulatory Education for Industry (REdI) Annual Conference 2023

April 19, 2023

• FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
• Impact Story: New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
• Public Notifications:
  • DYNAMITE Male Sexual Enhancement contains hidden drug ingredients
  • NUX Male Enhancement contains hidden drug ingredients
  • Pro Power Knight Plus 2550mg contains hidden drug ingredients
• Draft Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment

April 18, 2023

• Drugs@FDA Data Files (updated)
• Antifungal Susceptibility Test Interpretive Criteria: Rezafungin Injection
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
  • Testosterone Cypionate Injection (New - Discontinuation)

April 17, 2023

• CDER Conversations: The Office of New Drugs' Efforts to Expand Regulatory Science Research
• FDA Drug Shortages
  • Digoxin Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

April 14, 2023

• Drugs@FDA Data Files (updated)
• Drug Trial Snapshot: EMPAVELI
• Competitive Generic Therapy Approvals (updated)
• 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)

April 13, 2023

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

• Public Notification: AK Forte contains hidden drug ingredients
• SBIA Webinar: An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
• FDA announces new safety label changes for opioid pain medicines
• Drug Safety Communication: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
• FDA Drug Shortages
  • Albuterol Sulfate Inhalational Aerosol, Metered (New - Discontinuation)
  • Cisplatin Injection (Updated - Currently in Shortage)
  •  
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)

April 12, 2023

• Draft Guidance: Over-the-Counter Monograph Order Requests: Format and Content
• Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
• Draft Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry
• FDA Drug Shortages
  • Clonazepam Tablets (Updated - Currently in Shortage)
  • Epinastine Hydrochloride Ophthalmic Solution (New - Discontinuation)

April 11, 2023

• Drugs@FDA Data Files (updated)

April 7, 2023

• Public Notifications
  • American Bangster Optimum Formula 3000 contains hidden drug ingredient
  • American Bangster Black Label Optimum Formula 4000 contains hidden drug ingredient
  • Tantra Jelly Herbal Jelly for Him contains hidden drug ingredients
  • NORF 20 contains hidden drug ingredients

April 6, 2023

• Compounding Safety Information: Quinacrine Hydrochloride
• FDA Drug Shortages
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Mycophenolic Sodium Delayed-Release Tablets (New - Discontinuation)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)

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)