May 9, 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 Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar... Source: www.accessdata.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: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Determination of Topiramate Sprinkle Capsules Exclusivity Office of Generic Drugs: Determination of Topiramate Sprinkle Capsules Exclusivity Source: www.fda.gov Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic BRisk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Efalizumab (marketed as Raptiva) Information Efalizumab (marketed as Raptiva) Information Source: www.fda.gov Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide
FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ... Source: www.accessdata.fda.gov Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1 percent and Testim 1 percent, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure). Source: www.fda.gov President's FY 2010 Budget for FDA Invests Substantially in Food and Medical Product Safety The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget. Source: www.fda.gov May 8, 2009FDA Approves Drug for Treatment of Aggressive Brain Cancer FDA Approves Drug for Treatment of Aggressive Brain Cancer
The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. Source: www.fda.gov FDA: More than $1.5 Million of Adulterated Food, Food Ingredients Seized At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized more than $1.5 million worth of food products, including herbs and botanicals, stored under filthy conditions at the American Mercantile Corporation of Memphis, Tenn. Source: www.fda.gov Preventing Medical Errors: Don?t Share Insulin Pens Between Patients FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as h... Source: www.accessdata.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Sprout Recall Due to Potential Contamination with Listeria On April 9, 2009, Amalgamated Produce, Inc. announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov Warning on Raw Alfalfa Sprouts On April 26, 2009, FDA and CDC recommended that consumers not eat raw alfalfa sprouts until further notice because the product has been linked to Salmonella contamination. Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic
BRisk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov Recalls and Safety Alerts: Warning on Metoclopramide FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i... Source: www.accessdata.fda.gov FDA's MedWatch Safety Alerts: April 2009 A look at some of the recent safety alerts on medical products. Source: www.fda.gov PDUFA update The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009 Source: www.fda.gov Pediatric Exclusivity Granted BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated) Source: www.fda.gov FDA updates action on Plan B (levonorgestrel) tablets FDA updates action on Plan B (levonorgestrel) tablets Source: www.fda.gov Sprout Recall Due to Potential Contamination with Listeria On April 9, 2009, Amalgamated Produce, Inc. announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. Source: www.fda.gov May 7, 2009Guidance for Industry Guidance for Industry
Comprehensive List of Guidance Documents Source: www.fda.gov FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Source: www.fda.gov Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Recall of dietary supplements found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml Current Drug Shortages: Cisplatin Injection 1mg/ml, updated related information Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (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 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Source: www.fda.gov Personal Care Non-Acetone Nail Polish Remover Personal Care Non-Acetone Nail Polish Remover
Nationwide recall issued because of the potential for the product to cause chemical burns to the fingers of users. Source: www.fda.gov Libimax Recall of dietary supplement due to undeclared drug tadalafil, which may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section 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 Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets 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; Argatroban Injection See Related information section Source: www.fda.gov May 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 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: Amikacin sulfate injection Resolved Drug Shortages: Amikacin sulfate injection, No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information 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: Levoleucovorin (Fusilev) 50 mg single use vials Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials, see Related Information Section Source: www.fda.gov May 6, 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)
Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated); See Related Information Section 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: Alprostadil 0.5 mg/mL injection See Related Information section 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: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Increase in demand related to product recalls by other manufacturers Source: www.fda.gov CDER Organization Charts CDER Organization Charts
CDER Organization Charts (updated) Source: www.fda.gov Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs 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 Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov FDA has approved pancrelipase (Creon Delayed-Release Capsules) FDA has approved pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets, see Related Information Secrion for updated letter Source: www.fda.gov Guidance for Industry Individual Product Bioequivalence Recommendations Source: www.fda.gov Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book Source: www.fda.gov Guidance for Industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Source: www.fda.gov May 5, 2009Antiepileptic Drugs Antiepileptic Drugs
FDA approved updated labeling to warn about an increased risk of suicidal thoughts and behaviors. Source: www.fda.gov Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl... Source: www.accessdata.fda.gov May 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 Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Recall of dietary supplements found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Source: www.fda.gov Personal Care Non-Acetone Nail Polish Remover Nationwide recall issued because of the potential for the product to cause chemical burns to the fingers of users. Source: www.fda.gov Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conductedf under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Source: www.fda.gov FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials, see Related Information Section Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Guidance for Industry Individual Product Bioequivalence Recommendations Source: www.fda.gov Raw Alfalfa Sprouts Linked To Salmonella Contamination The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time. Source: www.fda.gov Hydroxycut Products Hydroxycut Products
Dietary supplements are associated with serious liver injury, including liver failure, seizures, cardiovascular disorders, and rhabdomyolysis. Source: www.fda.gov FDA Warns Consumers to Stop Using Hydroxycut Products The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials Drug Shortages: Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials
Resolved Drug Shortages: Levoleucovorin (Fusilev) 50 mg single use vials, see Related Information Section Source: www.fda.gov Influend Cough and Cold Products Recall due to possibility of product being superpotent. Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump A defect in the up and/or down buttons, which would result in users being unable to change any programmed setting on the pump. Source: www.fda.gov Guidance for Industry Individual Product Bioequivalence Recommendations Source: www.fda.gov May 4, 2009Guidance for Industry Guidance for Industry
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Source: www.fda.gov Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conductedf under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection Resolved Drug Shortages: Leucovorin Calcium Solution for Injection, see Related Information Section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Acyclovir Injection Resolved Drug Shortages: Acyclovir Injection, APP currently has all presentations available and Bedford currently reports available product for drop shipment Source: www.fda.gov Manual of Policies and Procedures (MaPP) Scientific Interest Groups: Criteria and Policies Source: www.fda.gov Guidance for Industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Source: www.fda.gov Warning on Raw Alfalfa Sprouts On April 26, 2009, FDA and CDC recommended that consumers not eat raw alfalfa sprouts until further notice because the product has been linked to Salmonella contamination. Source: www.fda.gov Personal Care Non-Acetone Nail Polish Remover Personal Care Non-Acetone Nail Polish Remover
Nationwide recall issued because of the potential for the product to cause chemical burns to the fingers of users. Source: www.fda.gov Guidance for Industry Comprehensive List of Guidance Documents Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Acyclovir Injection Resolved Drug Shortages: Acyclovir Injection, APP currently has all presentations available and Bedford currently reports available product for drop shipment Source: www.fda.gov Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been... Source: www.accessdata.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov May 3, 2009Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 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: 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: Methotrexate injection Current Drug Shortages: Methotrexate injection: Bedford Laboratories- manufacturing delays, Hospira- unable to meet demand, GeneraMedix- increase in demand and APP has product available. See Related Information section for more information 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 Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters 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 Pistachio Recall Expanded Pistachio Recall Expanded
On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. Source: www.fda.gov Determination of Topiramate Sprinkle Capsules Exclusivity Office of Generic Drugs: Determination of Topiramate Sprinkle Capsules Exclusivity Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml Current Drug Shortages: Cisplatin Injection 1mg/ml, updated related information Source: www.fda.gov Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Amikacin sulfate injection Resolved Drug Shortages: Amikacin sulfate injection, No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin |
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