Unilife Corporation Secures FDA 510k Clearance for the Unitract™ 1mL Tuberculin Syringe
LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).
The Unitract™ TB syringe is a variant of the 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 of 1mL syringes is the world's first and only known syringe that allows 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. 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.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "U.S. FDA 510k market clearance for our Unitract™ TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance. With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract™ TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."
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