May 23, 2009Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated 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; Argatroban 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: Current Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Related information section for posted letter 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 Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. 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 Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov May 22, 2009Drug Shortages: Current Drug Shortages: Acyclovir Injection Drug Shortages: Current Drug Shortages: Acyclovir Injection
See Related Information section for updated 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 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: 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: Mitomycin for injection (updated) Current Drug Shortages: Mitomycin for injection: See updated Related Information Section Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website 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: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. 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: Current Drug Shortages; Alprostadil 0.5 mg/mL injection 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: Current Drug Shortages; Leucovorin See web site for additional information 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 Drug Shortages: Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated) Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, See Company Information for updated contact information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Isoniazid Injection (NDC 00781-3056-70) Current Drug Shortages: Isoniazid Injection (NDC 00781-3056-70), Product continues to be available with short expiration dating, Sandoz has continued to make isoniazid injection available and the product may be ordered through wholesalers, Sandoz (customer service number) 1-800-525-8747 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: 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 Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter 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 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 Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section 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: 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: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated) Drug Shortages: Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated)
Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, See Company Information for updated contact information 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: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution (updated) Current Drug Shortages: Morphine Sulfate Oral Solution, See updated Dear Healthcare Provider Letter in the Related Information section 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 May 21, 2009Warning on Hydroxycut Products 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 updates action on Plan B (levonorgestrel) tablets FDA updates action on Plan B (levonorgestrel) tablets Source: www.fda.gov April First-Time Generic Drug Approvals Office of Generic Drugs: April First-Time Generic Drug Approvals 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: 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 New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling. Source: www.fda.gov Guidance for Industry Guidance for Industry
Individual Product Bioequivalence Recommendations Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Fentanyl transdermal patch (updated) Resolved Drug Shortages: Fentanyl transdermal patch, See update in Company name for Teva, in the Related Information section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, Bioniche Pharma has available the Enlon Plus 5 mL ampule (NDC 67457-0192-05) and the Enlon (NDC 67457-0190-15). The Enlon Plus multi- dose vials (NDC 67457-0191-15) are anticipated to be available soon. 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 Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators Current Drug Shortages: Technetium Tc99m Generators, Reduced supply due to material sourcing issues, Covidien: 1-888-744-1414 (Ultra-Technekow DTE, NDA 17-243) and Lantheus: 1-800-299-3431 (Technelite, NDA 17-771) 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 Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov May 20, 2009Digoxin, USP 0.25 mg Digoxin, USP 0.25 mg
UPDATE - Recall due to variance in amount of active ingredient. 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 Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003 Class I recall issued because the monitors may fail to sound an alarm. 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 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 Tarceva (erlotinib) Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Dexrazoxane for Injection, Zinecard 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: Resolved Drug Shortages: Amikacin sulfate injection Resolved Drug Shortages: Amikacin sulfate injection, No further supply issues are anticipated Source: www.fda.gov May 19, 2009Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled 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 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 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 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 Tarceva (erlotinib) Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. Source: www.fda.gov April 2009 Safety-Related 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 Hydroxycut Products Dietary supplements are associated with serious liver injury, including liver failure, seizures, cardiovascular disorders, and rhabdomyolysis. Source: www.fda.gov Digoxin, USP 0.25 mg UPDATE - Recall due to variance in amount of active ingredient. 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: Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated) Drug Shortages: Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated)
Resolved Drug Shortages: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection, See Company Information for updated contact information Source: www.fda.gov Pistachio Recall Expanded On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. 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 Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs Source: www.fda.gov Hydroxycut Products Dietary supplements are associated with serious liver injury, including liver failure, seizures, cardiovascular disorders, and rhabdomyolysis. Source: www.fda.gov May 18, 2009Warning on Raw Alfalfa Sprouts 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 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 Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. 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 FDA's MedWatch Safety Alerts: April 2009 A look at some of the recent safety alerts on medical products. Source: www.fda.gov FDA 101: Health Fraud Awareness Learn how to spot health fraud and avoid it. Source: www.fda.gov H1N1 Flu: FDA Responds Quickly to Protect the Public's Health FDA is addressing the H1N1 flu outbreak with a team-based incident management approach. 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: Current Drug Shortages; Leucovorin Drug Shortages: Current Drug Shortages; Leucovorin
See web site for additional information Source: www.fda.gov Guidance for Industry Submission of Summary Bioequivalence Data for ANDAs Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (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 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 Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products Source: www.fda.gov FDA updates action on Plan B (levonorgestrel) tablets FDA updates action on Plan B (levonorgestrel) tablets Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated) Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg), See updated Company Information section on Xanodyne Pharmaceuticals, Inc Source: www.fda.gov Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
See information in Related Information section. 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: Resolved Drug Shortages; Argatroban Injection See Related information section 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 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: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov May 17, 2009Drug Shortages: Resolved Drug Shortages: Amikacin sulfate injection 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 Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov |
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