BioAlliance Pharma Obtains European Approval For Loramyc(R) Tablet Embossing And Extension Of Its Shelf Life To 36 Months

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jul 2009 - 6:00 PDT

email to a friend   printer friendly   opinions  

BioAlliance Pharma SA (Paris:BIO), the specialty pharmaceutical company focused on therapy and supportive care in cancer and AIDS, announced Europe-wide approval for embossing its Loramyc® mucoadhesive buccal tablet, developed for the treatment of oropharyngeal candidiasis.

The embossing process has thus been approved under the Mutual Recognition Procedure; it was first required for the US market, where BioAlliance Pharma submitted a new drug application for Loramyc® to the Food and Drug Administration (FDA) in June 2009. BioAlliance Pharma will be able to harmonize Loramyc® production within those two key markets.

BioAlliance Pharma also received European approval for extension of Loramyc®'s shelf life from 18 to 36 months.

These two key industrial parameters are complementary assets for Loramyc® and will help optimizing manufacturing, storage and distribution costs.

Source
BioAlliance Pharma

• Additional
• References
• Citations