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Updated Monday through Friday

May 25, 2022

FDA Drug Shortages
- Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
- Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
Final Guidance for Industry: Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide

May 24, 2022

Draft Guidance for Industry: Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
Drugs@FDA Data Files (updated)
FDA Drug Shortages
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Diflunisal Tablets (Updated - Currently in Shortage)
- Fluvoxamine ER Capsules (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

May 23, 2022

Impact Story: Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

May 20, 2022

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
FDA Drug Shortages
- Bumetanide Injection (Updated - Currently in Shortage)
- Cladribine Injection (New - Discontinuation)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
- Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)

May 19, 2022

Drugs@FDA Data Files (updated)
Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (updated)
Draft Guidance for Industry: Risk Management Plans to Mitigate the Potential for Drug Shortages
FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
- Fluvoxamine ER Capsules (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
Patent Certifications and Suitability Petitions (updated)

May 18, 2022

FDA Drug Shortages
- Nedocromil Sodium Ophthalmic Solution (New - Discontinuation)
- Umbrasilib Tosylate Tablets (New - Discontinuation)
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (final guidance)

May 17, 2022

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (final guidance)
Competitive Generic Therapy Approvals (updated)
Drugs@FDA Data Files (updated)
FDA Drug Shortages
- Daptomycin Injection (New - Discontinuation)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)

May 16, 2022

FDA Drug Shortages
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lutetium Lu 177 Dotatate (LUTATHERA) Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
Final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

May 13, 2022

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)
FDA Drug Shortages (New)
5/9/2022
- Iodixanol (Visipaque) Injection (Currently in Shortage)
- Iohexol (Omnipaque) Injection (Currently in Shortage)
- Methocarbamol Injection (Discontinuation)
- Risedronate Sodium Tablets (Discontinuation)
FDA Drug Shortages (Updated)
5/12/2022
- Methylprednisolone Acetate Injection (Currently in Shortage)
- Potassium Acetate Injection (Currently in Shortage)
- Rifampin Injection (Currently in Shortage)
- Sodium Acetate Injection (Currently in Shortage)
- Sodium Phosphates Injection (Currently in Shortage)
5/10/2022
- Atropine Sulfate Injection (Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Currently in Shortage)
- Bacteriostatic Water for Injection (Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Currently in Shortage)
- Dexmedetomidine Injection (Currently in Shortage)
- Dextrose 50% Injection (Currently in Shortage)
- Diltiazem Hydrochloride Injection (Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Currently in Shortage)
- Dobutamine Hydrochloride Injection (Currently in Shortage)
- Dopamine Hydrochloride Injection (Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Furosemide Injection (Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Currently in Shortage)
- Ibutilide Fumarate Injection (Currently in Shortage)
- Lorazepam Injection (Currently in Shortage)
- Methylprednisolone Acetate Injection (Currently in Shortage)
- Midazolam Injection (Currently in Shortage)
- Morphine Sulfate Injection (Currently in Shortage)
- Pantoprazole Sodium for Injection (Currently in Shortage)
- Pentostatin Injection (Currently in Shortage)
- Potassium Chloride Concentrate Injection (Currently in Shortage)
- Propofol Injectable Emulsion (Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Currently in Shortage)
- Sodium Bicarbonate Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
- Sterile Water for Injection (Currently in Shortage)
- Sulfasalazine Tablets (Currently in Shortage)
5/9/2022
- Potassium Chloride Concentrate Injection (Currently in Shortage)

May 12, 2022

FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)

May 11, 2022

From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time | FDA

May 10, 2022

CDER Statement: CDER Launches New Accelerating Rare disease Cures (ARC) Program
Drugs@FDA Data Files (updated)
Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)

May 9, 2022

FDA & American College of Rheumatology (ACR) Virtual Summit
Draft Guidance for Industry: Benefit-Risk Considerations for Product Quality Assessments

May 6, 2022

Drugs@FDA Data Files (updated)
Competitive Generic Therapy Approvals (updated)

May 5, 2022

FDA Drug Shortages
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Levoleucovorin Injection (New - Discontinuation)
Spotlight on CDER Science: A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability

May 4, 2022

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer
Draft Guidance for Industry: Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
CDER Conversation: FDA Updates on Paxlovid for Health Care Providers (new)
FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cytarabine 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)
- 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)
- 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)
- Lipid Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Rifampin Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (New - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)

May 3, 2022

FDA Drug Shortages
- Dexmedetomidine Injection (Updated - Currently in Shortage)

May 2, 2022

FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Fluorescein Injection (New - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Tacrolimus Capsules (Updated - Resolved)
Foreign language translations of FDA works to protect consumers from potentially harmful OTC skin lightening products
- Hindi (हिन्दी) - शीर्षक: FDA उपभोक्ताओं को संभावित रूप से हानिकारक OTC स्किन लाइटनिंग उत्पादों से बचाने के लिए काम करता है
- Korean (한국어) - 제목: FDA는 잠재적으로 유해한 OTC 피부 미백 제품으로부터 소비자를 보호하기 위해 노력합니다
- Simplified Chinese (中文) - 标题：FDA 致力保护消费者免受潜在有害的非处方美白产品的危害
- Somali (somaliyeed) - Ciwaanka: FDA waxay ka shaqeysaa inay ka ilaaliso macaamiisha badeecada iftiiminta maqaarka ee OTC ee waxyeelada leh
- Spanish (Español) - Título: La FDA se esfuerza por proteger a los consumidores de productos de venta sin receta para aclarar la piel que son potencialmente dañino
- Tagalog (Tagalog) - Pamagat: Nagtatrabaho ang FDA para protektahan ang mga mamimili mula sa potensyal na mapanganib na OTC na mga produkto sa pagpapaputi ng balat
- Vietnamese (Tiếng Việt) - Tiêu đề: FDA hành động nhằm bảo vệ người tiêu dùng khỏi các sản phẩm làm sáng da không kê đơn có khả năng gây hại

April 29, 2022

Guidances for Industry
FDA Drug Shortages
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Ibutilide Fumarate Injection (New - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Technetium Tc 99m Sulfur Colloid Injection (Updated - Resolved)

April 28, 2022

Draft Guidance for Industry: Crohn’s Disease: Developing Drugs for Treatment
Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment

April 27, 2022

CDER Conversations: Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts
FDA Drug Shortages
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Lipid Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
Final Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports

April 26, 2022

April 25, 2022

Public Notifications: