What's New Related to Drugs

 

Get Email Updates for this Page
More Email Subscriptions Related to Drugs
RSS Feed for This Page

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 

 

November 25, 2020

• The Office of Prescription Drug Promotion (updated)

November 24, 2020

• Drugs@FDA Data Files (updated)
• Public Notifications:
  • 11/24/2020 V8 Super Energy contains hidden drug ingredient
  • 11/24/2020 U.S.A Viagra contains hidden drug ingredient
  • 11/24/2020 Stree Overlord contains hidden drug ingredients
  • 11/24/2020 Rhinozen 69 Platinum 25000 contains hidden drug ingredient
  • 11/24/2020 Rhino 99 Extreme 90000 contains hidden drug ingredient
  • 11/24/2020 Rhino 96 Platinum 77000 contains hidden drug ingredient
  • 11/24/2020 Rhino 69 Power 500K contains hidden drug ingredient
  • 11/24/2020 Rhino 69 Platinum 75000 contains hidden drug ingredient
  • 11/24/2020 Rhino 8 Platinum 80000 contains hidden drug ingredient
  • 11/24/2020 Magnum XXL 9800 contains hidden drug ingredient
  • 11/24/2020 Magnum XXL 50K contains hidden drug ingredient
  • 11/24/2020 Herb Viagra Male Sexual Stimulant contains hidden drug ingredient
  • 11/24/2020 Bigger Longer More Time More Sperms (sic) contains hidden drug ingredient
  • 11/24/2020 Body Shape Weight Loss System contains hidden drug ingredient
• Guidance for Industry:
  • Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
  • Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff

November 23, 2020

• CDER Compliance Conference - 01/14/2021 - 01/14/2021

November 20, 2020

• CDER Warning Letters (updated)
• Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry
• FDA Drug Shortages
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine 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)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)   
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

November 19, 2020

• OPDP Frequently Asked Questions (FAQs) (updated)
• FDA Drug Shortages
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
• Guidance for Industry:
  • Cross Labeling Oncology Drugs in Combination Drug Regimens
  • Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

November 18, 2020

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Pindolol Tablets (Updated - Currently in Shortage)
• Public Notifications:
  • Livtone contains hidden drug ingredients
  • Vigorous Man contains hidden drug ingredient

November 17, 2020

• CDER Conversations: Reflecting on Biosimilar User Fee Amendments (BsUFA) II and preparing for the BsUFA III reauthorization process
• Coronavirus Treatment Acceleration Program (CTAP) (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Pindolol Tablets (Updated - Currently in Shortage)
• List of Determinations Including Written Request  (updated)

November 16, 2020

• Impact Story: Use of Cyclin-Dependent Kinase 4/6 Inhibitor with Hormonal Therapy in Metastatic Breast Cancer—Efficacy in Patient Subgroups
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Cefotaxime Sodium Injection (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Fenoldopam Mesylate (Corlopam) Injection, USP (New - Discontinuation)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Updated - Currently in Shortage)
  • Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Triamterene and Hydrochlorothiazide (Dyazide) Capsules (New - Discontinuation)
• GDUFA III Reauthorization Negotiation Sessions (updated)

November 13, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Haloperidol Lactate (Haldol) Injection (New - Discontinuation)
  • Haloperidol Lactate Injection (New - Discontinuation)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Timolol Maleate Ophthalmic Gel Forming Solution (Updated - Currently in Shortage)
  • Timolol Maleate Ophthalmic Solution (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)

November 12, 2020

• DDT COA #000133: Small Cell Lung Cancer PRO
• DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous Lupus Erythematosus
• DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index in Systemic Lupus Erythematosus
• DDT COA #000138: Opioid Craving PRO
• FDA Drug Shortages
  • Loxapine Capsules (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 4200.1 Rev.1 Procedures for Review of Protocols Referred By DEA That use Schedule I controlled Substances and Drugs

November 10, 2020

• Impact Story: Improving the Design of Clinical Trials of Drugs to Treat Schizophrenia
• FDA Drug Shortages
  • Doxycycline Hyclate Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)

November 9, 2020

• Phonetic and Orthographic Computer Analysis (POCA) Program (updated)
• Drug Trials Snapshots (updated)
• Upcoming Webcast: Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA
• Guidance for Industry:
• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 
• Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs 

November 6, 2020

• CDER’s Efforts to Help Improve the Quality of Drug Compounding Include an Ongoing Focus on Insanitary Conditions (new)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
• Jobs in Oncology/Hematology (updated)

November 5, 2020

• CDER Warning Letters (updated)

November 4, 2020

• CDER Statement:  FDA Updates and Press Announcements on NDMA in Metformin (updated)

November 3, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Etomidate Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
• Spanish Language Drug Safety Communication (DSC): La FDA recomienda evitar el uso de medicamentos AINE durante el embarazo y a partir de las 20 semanas en adelante porque pueden reducir el nivel de líquido amniótico

November 2, 2020

• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Timolol Maleate Ophthalmic Solution (Updated - Currently in Shortage)
• Orange Book Data Files (compressed) (updated)
• Regulatory Policy Information (updated)

October 30, 2020

• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)

October 28, 2020

• A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 6701.3 Rev.1 Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy
  (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures
• Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry

October 27, 2020

• Drug Trials Snapshots: VEKLURY
• FDA Drug Shortages
  • Cysteamine Hydrochloride Ophthalmic Solution (New - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (New - Discontinuation)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Medroxyprogesterone Acetate (Depo-Provera) Injection, Suspension (New - Discontinuation)
  • Methocarbamol Tablet, USP (New - Discontinuation)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
• Referencing Approved Drug Products in ANDA Submissions Guidance for Industry

October 26, 2020

• From Our Perspective: The Orange Book at 40: A valued FDA resource continually enhanced by user input