FDA Approval: Unilife Cleared For Tuberculin Syringe
September 2, 2010 (FinancialWire) (Go to http://www.financialwire.net/?s=ftrdnwswnd for all of today’s featured news.) — Unilife Corp. (NASDAQ: UNIS) said that its Unitract Tuberculin Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration. The Unitract TB syringe is a variant of the firm’s Unitract 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes, which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.
The Unitract range is designed to allow operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
According to Unilife, the products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse.
Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication.
Production of the Unitract 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pennsylvania.
Pennsylvania-based Unilife is a medical device company focused on the design, development, manufacture and supply of a range of retractable syringes.
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