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2006-10-12 News Release

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Ciba Specialty Chemicals submits master file to FDA

A master file for its silver based antimicrobials solutions for medical device applications has been submitted to the FDA by Ciba Specialty Chemicals.

Ciba Specialty Chemicals has submitted a master file to the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA) for its silver based antimicrobials for medical device applications. The master file can be immediately cross referenced by marketers and developers of devices containing the novel, silver based technology to support regulatory approvals. The comprehensive data set contained in the master file includes anticipated device applications, chemistry, and toxicology data along with detailed descriptions of manufacturing, labelling, packaging, and distribution processes and practices and the associated quality controls that are in place. Ciba plans to submit additional master files for related products to the FDA in the future.

Find Information and Suppliers of antimicrobial solutions.

Metallic silver technology for antimicrobial solutions for medical devices. Click Go for Larger image. photo: Ciba

The master file for silver based antimicrobials submitted to the FDA provides key supportive data to facilitate the US approval process of medical devices. -> ->

. Master file provides key supportive data to facilitate US approval of medical devices containing this antimicrobial agent
. Metallic silver technology covers the growing demand for antimicrobial solutions for medical devices
. Submission of master files for further products planned

HyGentic* 4000, a form of elemental silver with unique physical properties was developed by Bio-Gate AG and is distributed globally by Ciba Specialty Chemicals. It is particularly well suited for implanted or inserted medical devices where antimicrobial solutions are increasingly in demand. A similar antimicrobial technology developed by Bio-Gate designed for dental fillings is marketed in Europe.

Ciba Specialty Chemicals submitted the above referenced master file, MAF# 1456, to the FDA and received confirmation of its receipt on September 29, 2006.

* HyGentic* 4000 is a registered trademark of Bio-Gate AG and is distributed by Ciba Specialty Chemicals throughout the world.

Find Information about Ciba Specialty Chemicals.

Read a recent press release about - Masterbatch business of Ciba Specialty Chemicals changes hands to become part of a leading industry player, with a global presence in this field.

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