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Pharmalucence, Inc. Announces FDA Approval For Its Generic Sestamibi Kit
Pharmalucence, Inc., a leading supplier of radiopharmaceutical products, announced that it received approval from the U. S. Food and Drug Administration (FDA) Office of Generic Drugs for its Abbreviated New Drug Application (ANDA) to manufacture and market its Kit for the Preparation of Technetium Tc-99m Sestamibi Injection. The FDA has determined that Pharmalucence"s Sestamibi Kit is therapeutically equivalent to Cardiolite® 1, an imaging agent used in evaluating myocardial function and to detect coronary artery disease by localizing myocardial ischemia and infarction. The agent is also for use in breast imaging as a second line diagnostic after mammography to assist in the evaluation of breast lesions.
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Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks
An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received a second orphan drug designation in the US only weeks after a first designation was granted. The recent designation relates to Burkholderia cepacia pathogens that can cause lethal infections in cystic fibrosis patients. For Axentis Pharma AG of Zurich, Switzerland, both designations affirm the therapeutic potential of its product candidate Fluidosomes(TM)-tobramycin, whose unique microbiological profile sets it apart from other antibiotic formulations (including free tobramycin).
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Rotavirus Epidemics Affected By Falling Birth Rates
Fewer births in states such as California may be delaying the annual onset of a common intestinal virus in the southwest, according to epidemiologists. The timing of infectious outbreaks in other locations such as the northeast remains more or less unchanged.
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Jaloma Pacifiers Recalled Due To Choking Hazard

The Connecticut Department of Consumer Protection is notifying consumers about a voluntary recall announced by the U.S. Consumer Product Safety Commission. The recalled Jaloma Pacifiers were sold in retail stores in New Jersey and New York from February 2008 through March 2009, for approximately $1.00. Although not sold in Connecticut stores, this recalled product may have been purchased while visiting the above noted states or may have been sent to Connecticut as a gift. The pacifiers were manufactured in Mexico and imported by Gromex Inc., of Passaic, New Jersey. Although no injuries and/or incidents have been reported, the potential for injury is high due to the pacifier mouth guard and the ventilation holes are too small and fail to meet federal safety standards, for this reason, the pacifier poses a choking hazard to young children. This pacifier has a ring-shaped handle and a round-shaped mouth guard with two ventilation holes. "Jaloma" is printed on the handle side of the mouth guard and the nipple has a gel-like liquid inside. Consumer Protection Commissioner Jerry Farrell, Jr., strongly recommends that parents check their children"s pacifiers for this product and if found, immediately remove from the child"s use and contact Gromex for a full refund or exchange. For additional information, please contact Gromex collect at (973) 458-9399, Monday through Friday, from 9:00 a.m. to 5:00 p.m., Eastern Time. Connecticut Department of Consumer Protection


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