FDA General
<ѻýҕl>FDA Panel Rejects Cystic Fibrosis Drugѻýҕl>
SILVER SPRING, Md. -- An FDA advisory committee has voted against approval of liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency, saying there is not enough evidence that the drug works better than agents already on the market.
Jan 12, 2011
<ѻýҕl>Novartis Settles Civil and Criminal Cases for $422.5 Millionѻýҕl>
Novartis will pay a $185 million fine for promoting off-label uses of the antiepilepsy drug oxcarbazepine (Trileptal) and another $237.5 million in civil penalties to settle a suit involving Trileptal and five other drugs, the Department of Justice announced.
Oct 01, 2010
<ѻýҕl>Take Rosiglitazone Off the Market, Says FDA Staffѻýҕl>
WASHINGTON -- Rosiglitazone (Avandia) should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.
Jul 09, 2010
<ѻýҕl>FDA Advisers Turn Down New RSV Drugѻýҕl>
WASHINGTON -- An FDA advisory committee recommended Wednesday that the agency not approve the investigational drug motavizumab to treat respiratory infections, deciding that it didn't offer any advantages over the drug already on the market, and that it may be more dangerous.
Jun 03, 2010