May 16, 2009Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection)
Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection), updated related information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva 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: Dexrazoxane for Injection, Zinecard Current Drug Shortages: Dexrazoxane for Injection, Zinecard, Manufacturing delays, Totect remains in limited availability, labeled for use in treatment of extravasation resulting from IV anthracycline chemotherapy. TopoTarget inquiries: 1-866-470-8247 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Methotrexate injection 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 BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products Source: www.fda.gov Drug Shortages: Current Drug Shortages: Dexrazoxane for Injection, Zinecard Current Drug Shortages: Dexrazoxane for Injection, Zinecard, Manufacturing delays, Totect remains in limited availability, labeled for use in treatment of extravasation resulting from IV anthracycline chemotherapy. TopoTarget inquiries: 1-866-470-8247 Source: www.fda.gov Antiepileptic 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: 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 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 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 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 New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) 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 BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Itching for Allergy Relief? Strategies for treating seasonal allergies. 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 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 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 Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Source: www.fda.gov May 15, 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 Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: Ben Venue is shipping product, with allocation in effect, customer service: 1-800-562-4797 Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt 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 May 14, 2009Digoxin, USP 0.25 mg Digoxin, USP 0.25 mg
UPDATE - Recall due to variance in amount of active ingredient. Source: www.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov Memorandum of Meeting Minutes: Drug Safety Oversight Board Meetings Drug Safety Oversight Board Meetings: Public Summaries, April 16, 2009 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 Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov Antiepileptic Drugs FDA approved updated labeling to warn about an increased risk of suicidal thoughts and behaviors. Source: www.fda.gov May 13, 2009Drugs@FDA Downloadable Data Files (updated) 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 Testosterone Gel Safety Information Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide Source: www.fda.gov Guidance for Industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Source: www.fda.gov Memorandum of Meeting Minutes: Drug Safety Oversight Board Meetings Drug Safety Oversight Board Meetings: Public Summaries, April 16, 2009 Source: www.fda.gov Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov Guidance for Industry Labeling OTC Human Drug Products; Small Entity Compliance Guide 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 Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: Ben Venue is shipping product, with allocation in effect, customer service: 1-800-562-4797 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution Current Drug Shortages: Morphine Sulfate Oral Solution, see Related Information section Source: www.fda.gov Guidance for Industry Guidance for Industry
Comprehensive List of Guidance Documents 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: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Source: www.fda.gov FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml 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 Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Pediatric Exclusivity Granted BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated) Source: www.fda.gov Division of Drug Marketing, Advertising, and Communications: Presentations Division of Drug Marketing, Advertising, and Communications: Presentations (updated) Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) 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 May 12, 2009Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva Source: www.fda.gov Guidance for Industry Individual Product Bioequivalence Recommendations Source: www.fda.gov Efalizumab (marketed as Raptiva) Information Efalizumab (marketed as Raptiva) Information 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 Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets (updated) Current Drug Shortages: Metoprolol succinate extended release tablets: See updated letter in Related Information Section Source: www.fda.gov FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic and Myobloc FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Source: www.fda.gov Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs Source: www.fda.gov Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin Drug Shortages: Current Drug Shortages; Leucovorin
See web site for additional information Source: www.fda.gov Testosterone gel products (AndroGel and Testim) Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. 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 Biosite brand Triage Cardiac Panel Biosite brand Triage Cardiac Panel
Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov FDA updates action on Plan B (levonorgestrel) tablets FDA updates action on Plan B (levonorgestrel) tablets Source: www.fda.gov Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) 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 Paragraph IV Patent Certifications Office of Generic Drugs: Paragraph IV Patent Certifications (updated) Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets (updated) Current Drug Shortages: Metoprolol succinate extended release tablets: See updated letter in Related Information Section Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic and Myobloc FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: Ben Venue is shipping product, with allocation in effect, customer service: 1-800-562-4797 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 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 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 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: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information 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 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; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva 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 May 11, 2009Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection 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 Treating Cushing's Disease in Dogs Medications, including a recently approved drug, can help manage this disease that most commonly occurs in middle-aged and older dogs. Source: www.fda.gov Itching for Allergy Relief? Strategies for treating seasonal allergies. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution (updated) Current Drug Shortages: Morphine Sulfate Oral Solution, Roxane- has product available. See information in Related Information section, Mallinckrodt- Increased demand due to another manufacturer leaving the market, Lannett-Increased demand due to another manufacturer leaving the market, and Glenmark- Increased demand due to another manufacturer leaving the market Source: www.fda.gov Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals
FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The... Source: www.accessdata.fda.gov President's FY 2010 Budget for FDA Invests Substantially in Food and Medical Product Safety 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 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; Vinblastine Sulfate Injection See Related information section for posted letter 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: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays 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; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov May 10, 2009Sprout Recall Due to Potential Contamination with Listeria 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 Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Strengthened warnings in product labeling and boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. Source: www.fda.gov Determination of Topiramate Sprinkle Capsules Exclusivity Office of Generic Drugs: Determination of Topiramate Sprinkle Capsules Exclusivity 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 CDER Organization Charts CDER Organization Charts (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 Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Antiepileptic Drugs FDA approved updated labeling to warn about an increased risk of suicidal thoughts and behaviors. 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 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: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) 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: 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 |
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