Exhumador
05/08/14 13:41
Ha respondido al tema
Farmas USA
FLML consigue la exclusividad de su fármaco.
LYON, FRANCE--(Marketwired - Aug 4, 2014) - Flamel Technologies S.A. (NASDAQ: FLML) has received communication from the U.S. Food and Drug Administration (FDA) that all manufacturers of unapproved versions of neostigmine methylsulfate have been notified by the FDA to cease manufacturing of the unapproved product as of July 30, 2014. Current inventory in the channel of the unapproved product can continue to be sold. Flamel has not been provided with information on the inventory levels held by these manufacturers.
"We sincerely appreciate the communication from the FDA which clearly indicates their commitment to the integrity of the unapproved drugs initiative. Our inventories are sufficient to provide 100% of the market demand for neostigmine methylsulfate with Bloxiverz™, the only approved FDA-approved version of the product in the market," said Mike Anderson, Chief Executive Officer of Flamel.