March 28, 2009Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website for additional information Source: www.fda.gov Listing of OTC Active Ingredients Listing of OTC Active Ingredients sorted by alphabetical and by monograph Source: www.fda.gov Guidance for Industry Newly Added Bioequivalence Recommendations Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov Generic Drug Petition Tracking: Suitability Tracking Reports Generic Drug Petition Tracking: Suitability Tracking Reports Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension
See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection See Related Information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated Source: www.fda.gov Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter Class 1 Recall issued because software and battery usage failures were identified that result in a delay in or interruption of infusion that may cause serious injury and/or death. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Source: www.fda.gov FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners
The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov March 27, 2009FDA issues position on allowing patients with ALS access to Iplex under an IND FDA issues position on allowing patients with ALS access to Iplex under an IND
FDA issues position on allowing patients with ALS access to Iplex under an IND Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 No further supply issues are anticipated. See related information section for more information Source: www.fda.gov FDA's MedWatch Safety Alerts: March 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov March 26, 2009Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Source: www.fda.gov FDA issues Information for Healthcare Professionals for Insulin Pens FDA issues Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Cisplatin Injection 1mg/ml APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64). Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks. Bedford has all presentations, including Novaplus presentations, on backorder with no release date. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection (updated) Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection 10 mg/mL, Preservative Free, 50 mL vial, package of 1; 50 mL Novaplus vial, package of 1: Manufacturing Delays Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
See information in Related Information section. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) See Related Information section Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Source: www.fda.gov March 25, 2009February 2009 Safety Labeling Changes February 2009 Safety Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov FDA issues Information for Healthcare Professionals for Zonisamide FDA issues Information for Healthcare Professionals for Zonisamide Source: www.fda.gov Insulin Pens are Not for Sharing Insulin pens should not be used on multiple patients. Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) Follow-up Dear Healthcare Professional Letter added to the Related information section Source: www.fda.gov Generic Drug Petition Tracking: Suitability Tracking Reports Generic Drug Petition Tracking: Suitability Tracking Reports Source: www.fda.gov Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) See Web site for updated information Source: www.fda.gov Myfortic (mycophenolic acid) Healthcare professionals notified of new Myfortic Medication Guide to provide important safety information for patients. Source: www.fda.gov Meeting/Forum Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information Source: www.diahome.org Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Increase in demand related to product recalls by other manufacturers Source: www.fda.gov Recalls and Safety Alerts: Limitations of Skin Patch Testing for Diagnosing Hypersensitivity Reactions with Abacavir Recalls and Safety Alerts: Limitations of Skin Patch Testing for Diagnosing Hypersensitivity Reactions with Abacavir
FDA is cautioning healthcare professionals against using skin patch testing to immunologically confirm suspected cases of hypersensitivity reaction in patients treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziag... Source: www.accessdata.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets See Related information section for updated letter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. Class 1 Recall due to complaints received about difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator), and/or a suction tube (catheter) into the tracheostomy tube. Source: www.fda.gov FDA issues Information for Healthcare Professionals for Zonisamide FDA issues Information for Healthcare Professionals for Zonisamide Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov January 2009 Safety Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov March 24, 2009Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated)
Increase in demand related to product recalls by other manufacturers Source: www.fda.gov Guidance for Industry Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment Source: www.fda.gov Paragraph IV Patent Certifications Paragraph IV Patent Certifications
Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov March 23, 2009Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
See Web site for additional information Source: www.fda.gov Meeting/Forum Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information Source: www.diahome.org FDA issues position on allowing patients with ALS access to Iplex under an IND FDA issues position on allowing patients with ALS access to Iplex under an IND Source: www.fda.gov Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov Manual of Policies and Procedures Acceptance Criteria for Residual Solvents Source: www.fda.gov Drug Shortages: Current Drug Shortages: Amikacin sulfate injection Hospira has amikacin available; customer service: 877-946-7747. Teva anticipates their product will be available by the end of February 2009. Source: www.fda.gov Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products
Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products (updated) Source: www.fda.gov FDA issues Information for Healthcare Professionals for Zonisamide FDA issues Information for Healthcare Professionals for Zonisamide Source: www.fda.gov FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India Source: www.fda.gov Guidance for Industry Newly Added Bioequivalence Recommendations Source: www.fda.gov Transdermal Drug Patches with Metallic Backings: Risk of Burns during MRI Scans Public Health Advisory issued describing risk of skin burns during MRI scans. Source: www.fda.gov Zencore Plus Nationwide recall of supplement, found to contain an undeclared drug, which may cause life-threatening risk of sudden drop in blood pressure. Source: www.fda.gov Drug Safety Oversight Board Meetings Memorandum of Meeting Minutes, Drug Safety Oversight Board Meeting, January 15, 2009 Source: www.fda.gov Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter Class 1 Recall issued because software and battery usage failures were identified that result in a delay in or interruption of infusion that may cause serious injury and/or death. Source: www.fda.gov Meeting/Forum Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information Source: www.diahome.org March 22, 2009Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection
See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) See Related Information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Source: www.fda.gov FDA Warns Consumers About Potentially Contaminated Cheese FDA Warns Consumers About Potentially Contaminated Cheese
The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems. Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated)
Increase in demand related to product recalls by other manufacturers Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) See Related Information section Source: www.fda.gov December 2008 Safety Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov |
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