Filed Under (Anti Viral) by David on 04-04-2010
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The FDA has approved a supplemental NDA (sNDA) for generic oseltamivir phosphate (Tamiflu, Roche) capsules in strengths of 30 mg and 45 mg. The lower-dose capsules provide a convenient alternative for treating and preventing influenza types A and B in patients one year of age and older. Because the capsules have a longer shelf life (five years) than the liquid suspension formulation (two years), they also offer an improved option for government stockpiling to prepare for a pandemic.
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Filed Under (Drug News) by David on 03-02-2010
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An advisory panel of the FDA has recommended stronger warnings for the influenza zanamivir (Relenza drug, Glaxo-SmithKline). The panel wanted the label to mention the potential for abnormal psychiatric side effects, sometimes leading to death. The panel also recommended additional warnings for oseltamivir (Tamiflu, Roche).
The panel reviewed a small but rising number of cases, mostly in Japan. In the case of Tamiflu, erratic behavior, including jumping from buildings, resulted in deaths. The FDA described reports of approximately 700 cases of psychiatric adverse events for both drugs and 25 cases of pediatric deaths in patients taking Tamiflu. No fatalities were reported for Relenza.
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Filed Under (Anti Viral) by David on 10-01-2010
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Dronedarone tablets (Multaq, SanofiAventis) have been approved to help maintain normal heart rhythm in patients with a history of atrial fibrillation or atrial flutter. This drug is indicated for patients whose hearts have returned to normal rhythm or for those who need drug therapy or electric shock to restore a normal heartbeat.
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Filed Under (Skin Care) by David on 06-01-2010
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Protalix BioTherapeutics, Inc., has announced the approval of a protocol for prGCD, a proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of patients with Gaucher disease. This rare and serious lysosomal storage disorder is characterized by debilitating symptoms.
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Filed Under (Anti Viral) by David on 14-12-2009
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Shortages of Roche’s oral suspension of oseltamivir drags phosphate (Generic Tamiflu) in some areas in the U.S. is posing a risk of dosing errors related to the product’s concentration.
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