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October 18, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Master Files (updated)
• Drug Master Files Guidance for Industry
• La revisión de la FDA no encuentra un mayor riesgo de cáncer de próstata con los medicamentos para el mal de Parkinson que contienen entacapona (Comtan, Stalevo)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (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)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 17, 2019

• Public Notification: Skinny Pill contains hidden drug ingredient
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: AKLIEF
• FDA Drug Shortages
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance

October 16, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Buspirone HCl Tablets (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)
  • Levetiracetam Extended-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Vincristine Sulfate Injection, USP (Preservative-Free) (New - Currently in Shortage)
• Public Notification: UP2 contains hidden drug ingredient
• Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 15, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Bosentan Tablets (New - Discontinuation)
  • Doxycycline Hyclate Capsules (New - Discontinuation)
  • Difluprednate (Durezol) Ophthalmic Emulsion (Updated - Resolved)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Lamotrigine Tablets (New - Discontinuation)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 11, 2019

• CDER Alert: FDA advises consumers not to use Rompe Pecho cough syrup 
• FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
  • Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: BEOVU
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride Injection (New - Currently in Shortage)
• Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 10, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 9, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Alogliptin Tablets (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (New - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry
• Public Notification: CHU Dietary Supplement Product contains hidden drug ingredients
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 8, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 7, 2019

• Current Supply of Heparin for U.S. Market Not Impacted By African Swine Fever in China
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Aminophylline Injection, USP (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dextrose 25% 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)
  • 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)
  • Latanoprost Ophthalmic Solution 0.005% (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Morphine Sulfate and Naltrexone Hydrochloride (EMBEDA®) Extended-Release Capsules (New - Discontinuation)    
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection, USP (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Scopolamine Transdermal System (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)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 4, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 3, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Carisoprodol Tablets, USP (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (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 with Epinephrine (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (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)
  • Scopolamine Transdermal System (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 2, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (New - Currently in Shortage)
  • Morphine Sulfate Injection, USP (New - Discontinuation)
  • Olaratumab (Lartruvo) Injection (New - Discontinuation)
• Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment Guidance for Industry
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• List of Determinations Including Written Request (updated)

October 1, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Methocarbamol Tablets (Updated - Currently in Shortage)
  • Methyldopa Tablets (Updated - Currently in Shortage)
  • Penicillamine (Depen) Titratable Tablets (Updated - Resolved)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Timolol Maleate Tablets (Updated - Currently in Shortage)
  • Tolterodine Tartrate (Detrol LA) Extended Release Capsules (New - Discontinuation)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 30, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

September 27, 2019

• Drug Trials Snapshots: IBSRELA
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• FDA Drug Shortages
  • Dextrose 25% Injection (New - Currently in Shortage)
• Warning Letters 2019 (updated)

September 26 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality 
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines

September 25 2019

• Spectrum of Diseases/Conditions (updated)
• Pediatric Exclusivity Statistics (updated)
• Patent Certifications and Suitability Petitions (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (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)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Nystatin Oral Suspension (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Acetate 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)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 24, 2019

• FDA Drug Shortages
  • Atracurium Besylate Injection, USP (New - Discontinuation)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (New - Currently in Shortage)
  • Erythromycin Ophthalmic Ointment (Updated - Currently in Shortage)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 23, 2019

• Manual of Policies and Procedures (MAPP) 6701.1 Procedures for DMEPA Intra-Center Consult to DMPP on Patient-Oriented Labeling Submitted with Human Factors Validation Study Protocols (PDF)
• Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry
• FDA Drug Safety Podcast: FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
• FDA Drug Shortages
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Carisoprodol Tablets, USP (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Resolved)
  • Erythromycin Ophthalmic Ointment (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
• Drug Trials Snapshots: NOURIANZ
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry

September 20, 2019

• FDA Drug Shortages
  • Scopolamine Transdermal System (New - Currently in Shortage)
• La FDA advierte sobre la inflamación pulmonar poco frecuente, pero grave con Ibrance, Kisqali y Verzenio para el cáncer de mama
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 19, 2019

• Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error
• Drug Firm Annual Registration Status (updated)
• FDA Drug Shortages
  • Scopolamine Transdermal System (Updated - Currently in Shortage)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• Small Business Chronicles:  "Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

Resources For You

• New and Generic Drug Approvals
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