March 6, 2009Drug Shortages: Current Drug Shortages; Argatroban Injection Drug Shortages: Current Drug Shortages; Argatroban Injection
See Related information section Source: www.fda.gov Standard Costs for Components of the Process for the Review of Human Drug Applications Standard Costs for Components of the Process for the Review of Human Drug Applications Source: www.fda.gov FDA issues Updated Safety Information about Raptiva (efalizumab). FDA issues Updated Safety Information about Raptiva (efalizumab). 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 FDA issues Information for Healthcare Professionals for Zonisamide FDA issues Information for Healthcare Professionals for Zonisamide 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 Guidance for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov March 5, 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 March 2009 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov CDER Organization Charts CDER Organization Charts (updated) Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) 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Minutes, Drug Safety Oversight Board Meeting, January 15, 2009 Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov CellCept (mycophenolate mofetil) Medication Guide issued, providing important safety information, to be distributed to every patient who fills a CellCept prescription from this point forward. Source: www.fda.gov Metoclopramide-Containing Drugs 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 Raptiva (efalizumab) Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva. Source: www.fda.gov FDA Warns About Risk of Wearing Medicated Patches During MRIs 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 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 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 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 Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris. 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 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 March 2009 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov Zonisamide (marketed as Zonegran, and generics) Treatment with zonisamide can cause metabolic acidosis in some patients. Source: www.fda.gov March 4, 2009Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection
No further supply issues are anticipated 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: Current Drug Shortages; Leucovorin Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov March 3, 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; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) 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 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 Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review
FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris. Source: www.fda.gov 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 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; SecreFlo (porcine secretin for injection, 16 mcg/vial) 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 Ethex Corporation Product Recall Nationwide voluntary recall of products at wholesale and retail level because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. 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
FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India Source: www.fda.gov March 2, 2009Zonisamide (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 Raptiva (efalizumab) Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva. Source: www.fda.gov 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Source: www.pda.org Division of Drug Marketing, Advertising, and Communications: Submission Information Division of Drug Marketing, Advertising, and Communications: Submission Information Source: www.fda.gov Ethex Corporation Product Recall Nationwide voluntary recall of products at wholesale and retail level because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov Guidance for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis Source: www.fda.gov Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated) Source: www.fda.gov 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China The 2009 PDA/FDA Asia Pacific Pharmaceutical Ingredient Supply Chain Conference is jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA) as a result of a memorandum of understanding signed in September 2008. Source: www.pda.org Patients Are Asking: New Labels for Non-prescription Cough and Cold Medications Patients Are Asking: New Labels for Non-prescription Cough and Cold Medications
Most makers of nonprescription cough and cold medicines are voluntarily changing the labels on these products to say "do not use" for children under 4 years of age. New child resistant packaging and measuring devices are also being introduced. ... Source: www.accessdata.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website for additional information Source: www.fda.gov Preventing Medical Errors: Drug Name Confusion Between Kuric and Carac The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac ... Source: www.accessdata.fda.gov Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Source: www.fda.gov March 1, 2009Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland
Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland Source: www.fda.gov PQRI Workshop PQRI Workshop: Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products, March 9-10, 2009, Hyatt Regency Bethesda, Bethesda, MD. Program and registration Source: www.pqri.org _ 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 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 Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Drug shortage: Metoprolol succinate extended release tablets Drug shortage: Metoprolol succinate extended release tablets Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov |
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