UPDATE 1-Unilife gets FDA nod on insulin syringe from U.S. unit

Mon Apr 5, 2010 2:25pm EDT

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April 5 (Reuters) - Medical device company Unilife Corp (UNIS.O) (UNS.AX) said the U.S. health regulator gave additional marketing approval for its Unitract 1mL Insulin Syringes assembled at its Lewisberry, Pennsylvania facility.

Shares of the U.S.-based company were up 58 percent at $9.16 Monday afternoon on Nasdaq. They touched a high of $9.74 on the news of approval.

In August 2008, Unilife had first received U.S. Food and Drug Administration clearance for the Unitract 1mL Insulin Syringe assembled at the Shanghai facilities of a Chinese manufacturing partner. Unilife had needed the additional 510(k) clearance for U.S. assembled stock since the Lewisberry facility was considered new. The company shifted manufacturing of the syringes to its Lewisberry facility immediately. The company will now immediately file an additional marketing application with the FDA seeking clearance for the Unitract 1mL Tuberculin (TB) Syringe -- a variant of the insulin syringes -- in the U.S. facility, it said in a statement. (Reporting by Vidya L Nathan in Bangalore; Editing by Jarshad Kakkrakandy)

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