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Unilife Corporation Secures FDA 510k Clearance for the Unitract™ 1mL Tuberculin Syringe
Date:9/1/2010

o recently secured its EC certification to apply the CE Mark to its Unitract™ 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.

The Company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract™ 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.

About Unilife CorporationUnilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligati
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