March 14, 2009Drug Shortages: Current Drug Shortages: Amikacin sulfate injection 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 Drug Safety Oversight Board Meeting: Public Summary, February 19, 2009 Drug Safety Oversight Board Meeting: Public Summary, February 19, 2009 Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov Manual of Policies and Procedures Acceptance Criteria for Residual Solvents Source: www.fda.gov Zonisamide (marketed as Zonegran, and generics) Zonisamide (marketed as Zonegran, and generics)
Treatment with zonisamide can cause metabolic acidosis in some patients. Source: www.fda.gov March 13, 2009Paragraph IV Patent Certifications Paragraph IV Patent Certifications
Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Forum Conference - Cytokine Therapies: Novel Approaches for Clinical Indications, March 26 and 27, 2009, NYAS Conference Center, New York City, NY: This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Meeting Information. Source: www.nyas.org FDA Takes Action Against KV Pharmaceutical Company The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years. 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 FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. 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 to Meet with Drug Companies about REMS for Certain Opioid Drugs FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs Source: www.fda.gov Guidance for Industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format Source: www.fda.gov Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06) Additional Information: FDA and Graceway are working to resolve the shortage as soon as possible. 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 March 12, 2009Guidance for Industry Guidance for Industry
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8: Sterility Test General Chapter Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov 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 FDA issues Updated Safety Information about Raptiva (efalizumab). FDA issues Updated Safety Information about Raptiva (efalizumab). 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 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 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 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Source: www.fda.gov Drug Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection Alprostadil 0.5 mg/mL injection: Teva Pharmaceuticals: Manufacturing delays; Bedford: Manufacturing delays; Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. 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 Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch
See Related information section 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 March 11, 2009Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland (updated) 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 BPCA of 2007: List of Determinations including Written Request Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter Source: www.fda.gov Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov Manual of Policies and Procedures Acceptance Criteria for Residual Solvents Source: www.fda.gov FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. Source: www.fda.gov FDA Warns About Risk of Wearing Medicated Patches During MRIs Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today. Source: www.fda.gov Patients Are Asking: Caution Using Topical Anesthetics Prior to Mammography FDA is alerting patients and healthcare professionals about the potential danger of using topical anesthetics to relieve pain before having mammography or other medical procedures. The concern is that patients may apply these drugs improperly, which... Source: www.accessdata.fda.gov 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 Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection Drug Shortages: Current Drug Shortages: Acyclovir Injection
See Related Information section for updated information 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 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: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06) Additional Information: FDA and Graceway are working to resolve the shortage as soon as possible. Source: www.fda.gov March 10, 2009FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs 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 March 9, 2009Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep
Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ... Source: www.accessdata.fda.gov Patients Are Asking: Caution Using Topical Anesthetics Prior to Mammography FDA is alerting patients and healthcare professionals about the potential danger of using topical anesthetics to relieve pain before having mammography or other medical procedures. The concern is that patients may apply these drugs improperly, which... Source: www.accessdata.fda.gov FDA Warns About Risk of Wearing Medicated Patches During MRIs Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today. Source: www.fda.gov Patients Are Asking: Potentially Fatal Salmonella Infections from Pet Turtles Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant d... Source: www.accessdata.fda.gov FDA Shuts Down a Flour Tortilla Manufacturer for Repeated Violations The U.S. Food and Drug Administration (FDA) today announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval. Source: www.fda.gov FDA Takes Action Against KV Pharmaceutical Company The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years. Source: www.fda.gov Preventing Medical Errors: Preventing Dosing Errors with Alteplase In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i... Source: www.accessdata.fda.gov FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Source: www.fda.gov March 8, 2009Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch
See Related information section Source: www.fda.gov 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; Alprostadil 0.5 mg/mL injection Alprostadil 0.5 mg/mL injection: Teva Pharmaceuticals: Manufacturing delays; Bedford: Manufacturing delays; Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov BPCA of 2007: List of Determinations including Written Request Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated) Source: www.fda.gov Preventing Medical Errors: Preventing Dosing Errors with Alteplase In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i... Source: www.accessdata.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection See Related Information section Source: www.fda.gov Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008 Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008 Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection Drug Shortages: Current Drug Shortages: Mitomycin for injection
See Related Information section Source: www.fda.gov |
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