OravigTreatment for Oral Thrush
Update: Oravig (miconazole mucoadhesive buccal tablet) Now FDA Approved - April 16, 2010
Loramyc NDA Not Accepted by FDA
Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet
PARIS--(BUSINESS WIRE)--Apr 9, 2009 - 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.
About BioAlliance Pharma
As a preferred partner for hospital-based specialists, BioAlliance Pharma is a specialty biopharmaceutical company which develops and markets innovative products, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, our targeted approaches help overcome drug resistance and improve patient health & quality of life. BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs.
For more information, visit the BioAlliance Pharma web site at http://www.bioalliancepharma.com.
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forwardlooking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the reference document approved by the AMF on April 11 2008 under the number R. 08-021, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).
Contact: BioAlliance Pharma SA
Dominique Costantini, President and CEO
Tel.: +33 1 45 58 76 01
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
Posted: April 2009
- FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis - April 16, 2010
- BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis - August 19, 2009
- Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws - June 16, 2009
- Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009 - May 7, 2009