October 23, 2008Drug 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. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Drug Shortage: Fentanyl transdermal patch Availability information updated. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. 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 FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. # posted by Network @ 6:00 AM
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