Japan : Approval of Additional Indication of Ultrasound Contrast Agent SONAZOID(R) for Injection [TendersInfo (India)]

Daiichi Sankyo Co., Ltd. announced today that it has received approval in Japan for an additional indication for the ultrasound contrast agent, 16L vials of SONAZOID for injection, for the imaging of focal breast lesions.

SONAZOID is an ultrasound contrast agent consisting of microbubbles with increased stability under ultrasound fields, which enables continuous diagnostic scanning with an excellent contrast effect. SONAZOID was approved for market authorization in Japan, and ahead of other countries, in January 2007 for a focal liver lesion diagnosis indication.

A phase 3 confirmatory study in patients with focal breast lesions demonstrated a superiority of contrast-enhanced ultrasound with SONAZOID compared to that of unenhanced ultrasound in accuracy of tumor characterization. Moreover, tolerability was also shown. SONAZOID is expected to serve as a new option for the diagnosis of focal breast lesions and its disease management through its excellent diagnostic performance in differentiating benign and malignant lesions.

Outline of SONAZOID

Product name : SONAZOID 16L vial for injection

Generic name : Perflubutane

For ultrasound imaging associated with the following: Indications : Focal liver lesions, focal breast lesions (underlined represents additional or modified indication)

Administration, dosage : Suspend 16L (1 vial) of perflubutane microbubbles in the included 2mL injection solvent and administer the suspension intravenously. Usual dosage for an adult is 0.015mL/kg body weight in a single administration.

Licensor : GE Healthcare (Headquarter: UK).