BioAlliance Pharma to resubmit NDA for Loramyc to FDA

Published: 9-Apr-2009
Research & Development

The US Food and Drug Administration (FDA) has refused the NDA for BioAlliance Pharma's Loramyc (miconazole) mucoadhesive buccal tablet (MBT) because it did not have a tablet imprint code.


The US Food and Drug Administration (FDA) has refused the NDA for BioAlliance Pharma's Loramyc (miconazole) mucoadhesive buccal tablet (MBT) because it did not have a tablet imprint code.

The French pharmaceutical company, which specialises on the treatment of opportunistic infections in cancer and AIDS, said it will work closely with the FDA on the introduction of the debossed tablet and will soon after resubmit the application.

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 FDA needs 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.

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