FOR IMMEDIATE RELEASE

Contact:
David Dalton
Business Development Manager
In.vision research Corp.
ddalton@invisionresearch.com
(727) 822-7200
 

GeneraMedix Selects In.vision Xpress Author for Production of Structured Product Labels (SPL)

Saint Petersburg, Florida January 25, 2007.

In.vision Research Corporation, the leading provider of software for enterprise XML authoring, announced today that GeneraMedix has joined the growing list of companies that have selected Xpress Author for Microsoft Word to prepare submission of structured product labels to the US Food and Drug Administration.

Under recent regulations, the Food and Drug Administration (FDA) expects drug manufacturers to submit prescribing and product information in a structured product labeling (SPL) format that provides accurate, up-to-date drug information using standardized medical terminology in a format that is both human and machine (computer) readable. Through the use of embedded computer tags, Structured Product Labels can be electronically managed, enabling a variety of data management and automation systems to be built. For example, Structured Product Labels can communicate to computers specifics about a product, including its, indications, dosage and administration, warnings, active and inactive ingredients, and other guidelines for usage.

“SPL labels are based upon a highly technical XML specification,” explains John Friske, In.vision CEO. “Despite all their benefits, creating SPL labels can be very difficult for pharmaceutical companies, whose labeling experts represent normal computer users who are not programmers or software technicians. Xpress Author allows these users to create the labels in Microsoft Word as they normally would, without being encumbered by technology.”

As the FDA receives SPL-formatted labeling information, healthcare professionals, patients, online information providers and other consumers are able to access the newly updated labels via the Internet, free of charge through the DailyMed system. Updated product labels will be posted on the site within one business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval.

With this information, physicians are able to quickly search and access specific information they need before prescribing a treatment, resulting in fewer prescribing errors and better informed decision making. In addition, having the labels submitted to FDA in SPL will improve the FDA drug labeling review process, so that FDA can provide immediate access to the most recent information about medications to doctors and patients.

The SPL project, led by FDA's Center for Drug Evaluation and Research, is the first in an agency-wide initiative regarding the public provision of electronic information. In the future Daily Med will also include labels for biologics (such as vaccines), medical devices, veterinary drugs and some food products. The SPL standard, part of the DailyMed project, is one of the initiatives implemented as part of an ongoing collaboration of federal agencies to apply modern principles of information science to translate, repackage and freely distribute up-to-date medication information in a reliable, accurate and consistent format. The group is dedicated to building a nationwide infrastructure for managing medication information to improve healthcare quality in the United States.

About GeneraMedix

GeneraMedix Inc. is a generic pharmaceutical company with a pipeline and a marketed product portfolio of injectable products, targeting the institutional market, (hospitals and surgery centers), alternate sites (including oncology clinics, dialysis centers, and home healthcare nursing) and retail pharmacies. For more information on GeneraMedix, please visit www.GeneraMedix.com