What's New Related to Drugs

What's New Related to Drugs

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July 18, 2019

• Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Dicyclomine Oral Tablets/Capsules (Updated - Currently in Shortage)
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Nelarabine (Arranon) Injection (Updated - Currently in Shortage)
  • Progesterone Injection, USP (Updated - Currently in Shortage)
  • Sildenafil Citrate (REVATIO) (Updated - Currently in Shortage)
• Office of Generic Drugs FY 2018 GDUFA Science and Research Report
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 17, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Carbidopa and Levodopa Extended Release Tablets (New - Discontinuation)
  • Dorzolamide Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (New - Currently in Shortage)
  • Epirubicin Hydrochloride Injection (New - Discontinuation)
  • Magnevist® (gadopentetate dimeglumine) Injection (New - Discontinuation)
  • Naratriptan Hydrochloride Tablets (New - Discontinuation)
  • Omeprazole Delayed-Release 40 mg Capsules (New - Discontinuation)
  • Stavudine Capsules (New - Discontinuation)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 16, 2019

• Public Notifications
  • Black Storm contains hidden drug ingredient
  • Big Penis contains hidden drug ingredient
  • Boss Lion 9000 contains hidden drug ingredient
  • De Guo Heijin Gang contains hidden drug ingredient
  • Herb Viagra contains hidden drug ingredient
  • La Pepa Negra contains hidden drug ingredient
  • Odimafo Powerful Tablet 200 mg contains hidden drug ingredient
  • Plant Vigra contains hidden drug ingredient
  • Shengjingpian contains hidden drug ingredient
  • Vigour 800 mg contains hidden drug ingredient
  • Reduktis Max contains hidden drug ingredient
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: XPOVIO
• National Drug Code Directory (updated)
• Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product  Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (revision 7)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 15, 2019

• 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)

July 12, 2019

• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: VYLEESI
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Resolved)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (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)
  • Metaproterenol Sulfate Tablets, USP (New - Discontinuation)   
  • Methotrexate Sodium 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 (Updated - Currently in Shortage)
  • Remifentanil (Ultiva) Lyophilized Powder for Solution Injection (Updated - Currently in Shortage)
  • Ribavirin Capsules and Tablets (New - Discontinuation)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sildenafil Citrate (REVATIO) (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Orange Book (updated)
  • Orange Book Current Cumulative Supplement
  • Additions/Deletions for Prescription and OTC Drug Product Lists
  • Orange Book Data Files (compressed)
  • Reference Listed Drugs by ANDA Reference Standard List
  • Orange Book Patent Listing Dispute List
  • Appendix A: Product Name Index
  • Appendix B: Product Name Sorted by Applicant
  • Appendix C: Uniform Terms
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 11, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry
• FDA Drug Shortages
  • Haloperidol Tablets (Updated - Currently in Shortage)
• Population Pharmacokinetics Guidance for Industry
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 10, 2019

• CDER Bio - Elizabeth Jungman, J.D., M.P.H., Director, Office of Regulatory Policy
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Manual of Policies and Procedures (MAPP) 4191.1 Risk Evaluation and Mitigation Strategies Modifications and Revisions
• FDA Drug Shortages
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dicyclomine Oral Tablets/Capsules (Updated - Currently in Shortage)
  • Diphenhydramine Injection (Updated - Currently in Shortage)
  • Eprosartan Mesylate Tablets (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Ketoprofen Capsules (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
  • Trifluoperazine Hydrochloride Tablets (Updated - Currently in Shortage)
• Using the Inactive Ingredient Database Guidance for Industry
• Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 9, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Lorazepam Injection, USP (New - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 6004.3 Safety Labeling Changes Under Section 505(o)(4) of the FD&C Act
• Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 8, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Spotlight on CDER Science: New FDA Study Shines Light on Sunscreen Absorption
• Drug Supply Chain Security Act Law and Policies (updated)
• Enhanced Communication (updated)
• FDA Drug Shortages
  • Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 5, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 3, 2019

• 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)

July 2, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

July 1, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry
• Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 28, 2019

• Office of Compliance Annual Report 2018 (PDF - 979KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Bupropion Hydrochloride (Zyban) Tablets (New - Discontinuation)
  • Carisoprodol Tablets, USP (New - Currently in Shortage)
  • Clindamycin Phosphate and Benzoyl Peroxide (Duac) Topical Gel (New - Discontinuation)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Ranitidine Injection, USP (New - Currently in Shortage)
  • Ropinirole Hydrochloride Extended Release (Requip XL) Tablets (New - Discontinuation)
  • Triamterene and Hydrochlorothiazide (Dyazide) Capsules (New - Discontinuation)
• Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations Guidance for Industry
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 27, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Sclerosol Intrapleural Aerosol (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 26, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Public Notifications:
  • Peru Maca contains hidden drug ingredient
  • Germany Black Gorilla contains hidden drug ingredient
  • Adelgasin Plus contains hidden drug ingredients
  • Super Slimming Herb contains hidden drug ingredient
  • Lishou Fuling Jiaonang contains hidden drug ingredients
  • Detoxi Slim contains hidden drug ingredient
  • Absolute Nine Slim contains hidden drug ingredients
• FDA Drug Shortages
  • Ranitidine Injection, USP (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (New - Currently in Shortage)
• Modernizing FDA's New Drugs Regulatory Program
• National Drug Code Directory (updated)
• E19 Optimisation of Safety Data Collection; International Council for Harmonisation; Draft Guidance for Industry
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 25, 2019

• Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Carisoprodol Tablets, USP (New - Currently in Shortage)
  • Carisoprodol Tablets, USP (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection Bags (New - Currently in Shortage)
  • Dextrose 5% Injection Bags (Updated - Currently in Shortage)
  • Eprosartan Mesylate Tablets (Updated - Currently in Shortage)
  • Haloperidol Tablets (Updated - Currently in Shortage)
  • Ketoprofen Capsules (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Levoleucovorin Calcium Injection (New - Discontinuation)
  • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Thioridazine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
  • Trifluoperazine Hydrochloride Tablets (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• CDER Small Business and Industry Assistance (SBIA) Chronicle: "Research Investigational New Drug Applications – What You Need To Know" June 25, 2019 Issue
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 24, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 21, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: POLIVY
• FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues
• FDA Drug Shortages
  • Potassium Chloride Injection (Updated - Resolved)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry
• RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance
• Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 20, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Hydromorphone Hydrochloride Extended-Release Tablets, CII (New - Discontinuation)
• Infusion Options Inc. Issues Voluntary Nationwide Recall of All Lots of All Sterile Products Due to Lack of Assurance of Sterility
• National Drug Code Directory (updated)
• Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 19, 2019

• 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)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Diphenhydramine Injection (Updated - Currently in Shortage)
  • Erythromycin Lactobionate for Injection, USP (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)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (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)
  • Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sterile Water (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

June 18, 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)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

Resources For You

• New and Generic Drug Approvals
• Meetings, Conferences, & Workshops (Drugs)
• Recently Updated Advisory Committee Materials
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• Tools To Keep You Informed