BioAlliance Pharma to complete NDA for Loramyc® with data on Debossed mucoadhesive tablet
9 Apr, 2009
BioAlliance Pharma SA (Euronext 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.