PARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Paris: BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, today announced that the FDA did not accept the NDA for Loramyc® (miconazole) mucoadhesive buccal tablet (MBT) to be filed based on the lack of a tablet imprint code. Loramyc® was approved in Europe in 2007 and is currently marketed in several EU territories including France, Germany, the UK, Sweden, Finland and Denmark. While the EU does not require a unique tablet identifier, the U.S. FDA does require a tablet imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of the debossed tablet and will soon after resubmit the Loramyc® application.
