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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

July 28, 2021

• Biosimilars | New Fact Sheets for Health Care Providers
  • Overview of Biosimilar Products (PDF – 2.48 MB) 
    Learn more about biosimilar products.
  • Biosimilar Regulatory Review and Approval (PDF – 1.81 MB) 
    Learn more about the approval process.
  • Interchangeable Biological Products (PDF – 1.52 MB)
    Learn more about interchangeable biological products.
• Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry
• FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide) (new)

July 27, 2021

• Drugs@FDA Data Files (updated)

• FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

• FDA Drug Shortages

  • Cisatracurium Besylate Injection (Updated - Resolved) 

July 26, 2021

• Public Notification: Hydro Pinapple [sic] Burn contains hidden drug ingredient (new)
• CDER Manual of Policies and Procedures (MAPP) 5230.3 Rev.1 Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act
• FDA Drug Shortages
  • Vancomycin Hydrochloride for Injection (New - Discontinuation)

July 23, 2021

• FDA Drug Shortages
  • Gentamicin Sulfate Injection (New - Currently in Shortage)

July 22, 2021

• FDA Drug Safety Podcast: FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
• FDA Drug Shortages
  • Disopyramide Phosphate (Norpace) Capsules (New - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
• FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma 
• Field Alert Report Submission: Questions and Answers Guidance for Industry

July 20, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Safety Communication: FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Anagrelide Hydrochloride Capsules (Updated - Resolved)
  • Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Famotidine Tablets (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)

July 16, 2021

• FDA Approves New Use of Transplant Drug Based on Real-World Evidence
• FDA approves belumosudil for chronic graft-versus-host disease
• 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality - 09/14/2021 - 09/15/2021
• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Midazolam Injection Updated - Currently in Shortage)
  • Misoprostol Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Varenicline Tartrate (Chantix) Tablets (New - Currently in Shortage)

July 14, 2021

• FDA Drug Shortages
  • Mepivacaine Hydrochloride Injection (New - Currently in Shortage)
• FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit (new)
• Competitive Generic Therapy Approvals (Updated)
• Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance

July 13, 2021

• CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 (update)
• FY 2022: Self-Identified Generic Drug Facilities, Sites and Organizations (update)
• Cumulative 503B Reported Drugs Used For Hospitalized Patients with COVID-19 (update)
• Drugs@FDA Data Files (updated)
• July 15, 2021 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement (update)
• January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) (new)
• From Our Perspective: CURE ID Moves to Automated Data Collection in Light of COVID Pandemic (new)
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)

July 12, 2021

• FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma (new)

July 9, 2021

• FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer
• FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes (new)
• Public Notifications:
  • X Rated Honey For Men contains hidden drug ingredient
  • Cholestene contains hidden drug ingredient
• FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products (update)
• 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)

July 8, 2021

• List of Drug Master Files (DMFs) (Updated)
• FDA Drug Shortages
  • Acetazolamide Injection (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)

July 7, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)

July 6, 2021

• Competitive Generic Therapy Approvals (update)
• FDA Drug Shortages
  • New
    • Albuterol Sulfate Aerosol, Metered (Discontinuation)
    • Diflorasone Diacetate Ointment, 0.05% (Discontinuation)
    • Metoclopramide Tablets (Discontinuation)
  • Updated
    • Acetazolamide Injection (Currently in Shortage)
    • Atropine Sulfate Injection (Currently in Shortage)
    • Azacitidine for Injection (Currently in Shortage)
    • Bumetanide Injection (Currently in Shortage)
    • Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
    • Dexmedetomidine Injection (Currently in Shortage)
    • Diltiazem Hydrochloride Injection (Currently in Shortage)
    • Enalaprilat Injection (Currently in Shortage)
    • Famotidine Injection (Currently in Shortage)
    • Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
    • Ketamine Injection (Currently in Shortage)
    • Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
    • Pantoprazole Sodium for Injection (Currently in Shortage)
    • Propofol Injectable Emulsion (Currently in Shortage)
    • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
    • Valproate Sodium Injection (Currently in Shortage)

July 2, 2021

• FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level
• Coronavirus (COVID-19) | Drugs (update)
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse (update)
• Compounding Activities | COVID-19 - Hospitals can use the product report to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.
• FDA Drug Shortages
  • Moxifloxacin (Moxeza) Ophthalmic Solution (New - Discontinuation)
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Chlordiazepoxide Hydrochloride Capsules (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)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
  • Nizatidine Capsules (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)

July 1, 2021

• Public Notification: Genesis Ultra Slim Gold contains hidden drug ingredients
• FDA Drug Shortages
  • Iopamidol (Isovue) Injection (Discontinuation)
• Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
• Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Guidance for Industry
• FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma
• Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

June 30, 2021

• Public Notification: 365 SKINNY High Intensity contains hidden drug ingredient
• FDA Drug Shortages
  • Misoprostol Tablets (Updated - Currently in Shortage)
• Search List of Extended Use Dates to Assist with Drug Shortages (update)
• Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (new)

June 29, 2021

• Assessment of the Use of Patient Experience Data in Regulatory Decision-Making
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dimercaprol (Bal in Oil) Injection (Updated - Resolved)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydralazine Hydrochloride Injection (Updated - Resolved)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Tipranavir Oral Solution (New - Discontinuation)