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Updated Monday through Friday  

• Drug Firm Annual Registration Status 
• Drug Firm Annual Registration Status Download File 
• National Drug Code Directory 
• NDC Unfinished Drugs Excluded Database File 
• NDC Database Excluded Packages and Products 
• Wholesale Distributor and Third-Party Logistics Providers Reporting 

February 28, 2020

• Guidance Snapshot Pilot

February 27, 2020

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diphenhydramine 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)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Metronidazole Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection, USP (Updated - Currently in Shortage)
  • Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)

February 26, 2020

• Drug Trial Snapshot: PIZENSY
• FDA Drug Shortages
  • AVYCAZ® (ceftazidime and avibactam) for Injection, 2 grams/0.5 grams (New - Currently in Shortage)
  • Dexrazoxane Injection (New - Resolved)
  • Dexrazoxane Injection (Updated - Resolved)
  • Levofloxacin Tablets (New - Resolved)
  • Levofloxacin Tablets (New - Discontinuation)
  • Olopatadine Hydrochloride (Pataday) Ophthalmic Solution (New - Discontinuation)
  • Olopatadine Hydrochloride (Pataday) Ophthalmic Solution (New - Discontinuation)
  • Triamcinolone Acetonide (Triesence) Injection, Suspension (Updated - Currently in Shortage)

February 25, 2020

• Drugs@FDA Data Files (updated)

February 24, 2020

• CDER Conversation: Real World Evidence - From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies
• FDA Drug Shortages
  • Dicyclomine Oral Tablets/Capsules (Updated - Currently in Shortage)
  • Didanosine Delayed-Release Capsules USP (New - Discontinuation)
• Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

February 21, 2020

• CDER Statement: FDA launches new resource to provide easily accessible, more accurate historical drug approval data
• Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
• Drug Shortages Report: Root Causes and Potential Solutions (updated February 2020)
• FDA Drug Shortages
  • Pindolol Tablets (New - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Resolved)
  • Sumatriptan Succinate Injection (New - Discontinuation)

February 19, 2020

• 2019 Office of Generic Drugs (OGD) Annual Report 
• FDA Drug Safety Podcast: FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
• FDA Drug Shortages
  • Cefazolin Injection (Updated - Currently in Shortage)
• Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry
• 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)

February 18, 2020

• FY2019 GDUFA Science and Research Report
• Drugs@FDA Data Files (updated)
• Drug Safety Communication (DSC) in Spanish: La FDA refuerza la advertencia de que el estreñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales

February 14, 2020

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Entecavir Tablets (New - Discontinuation)

February 13, 2020

• FDA Drug Safety Communication: FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
• FDA Drug Shortages
  • Diclofenac Sodium Topical Gel (New - Discontinuation)
  • Donepezil Hydrochloride Tablets (New - Discontinuation)
• Orange Book Preface (updated)

February 11, 2020

• Drugs@FDA Data Files (updated)

February 10, 2020

• 12th Annual FDA Sentinel Public Workshop
• CDER Warning Letters 2019 (updated)
• CDER Warning Letters 2020 (updated)
• FDA Drug Shortages
  • Fludarabine Phosphate for Injection, USP (New - Discontinuation)
  • Fluorouracil Injection (New - Discontinuation)
  • Tacrolimus Capsules (Updated - Currently in Shortage)

February 7, 2020

• FDA Drug Shortages
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dicyclomine Oral Tablets/Capsules (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Discontinuation)
  • Diphenhydramine Injection (Updated - Currently in Shortage)
  • Enalaprilat Injection, USP (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (New - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Promethazine (Phenergan) Injection (Updated - Currently in Shortage)

February 6, 2020

• Biosimilars and Interchangeable Biosimilars:  Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry

February 5, 2020

• Public Notifications:
  • OrgaZEN Gold 5800 contains hidden drug ingredient
  • Alpha-Male contains hidden drug ingredients
  • XXX Platinum WOODIE contains hidden drug ingredients
  • RMFLEX contains hidden drug ingredient

February 4, 2020

• Drug Trials Snapshots: TAZVERIK
• FDA Drug Shortages
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Ketoprofen Capsules (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry
• Drugs@FDA Data Files (updated)

February 3, 2020

• Laboratory Tests | Metformin
• Updates and Press Announcements on NDMA in Metformin
• Drug Trials Snapshots: JEUVEAU
• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry

January 31, 2020

• Drug Safety Communication (en Español): La FDA advierte acerca de problemas respiratorios graves con los medicamentos para convulsiones y dolor neural gabapentina (Neurontin, Gralise, Horizant) y pregabalina (Lyrica, Lyrica CR)
• FDA Drug Shortages
  • Levetiracetam Extended-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• FDA requests withdrawal of bacitracin for injection from market

January 30, 2020

• CDER Statement:  FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health
• FDA Drug Shortages
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Vincristine Sulfate Injection, USP (Preservative-Free) (Updated - Resolved)
• Manual of Policies and Procedures (MAPP) 5240.3 Rev.5 Prioritization of the Review of Original ANDAs, Amendments, and Supplements
• Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Guidance for Industry
• Guidance Agenda:  Guidances CDER is Planning to Develop During the Calendar Year 2020

January 29, 2020

• Drug Trial Snapshot: TEPEZZA
• FDA Drug Shortages
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
• Public Meeting on Patient-Focused Drug Development for Vitiligo

January 28, 2020

• Drug Safety Communication: FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (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 with Epinephrine (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• Drugs@FDA Data Files (updated)

January 27, 2020

• FDA Drug Shortages
  • Gatifloxacin Ophthalmic Solution (New - Discontinuation)
  • Methscopolamine Bromide Tablets (New - Discontinuation)
  • Pramipexole Dihydrochloride Extended Release Tablets (New - Discontinuation)

Resources For You

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