Sonus completes EchoGen filing

The Food and Drug Administration has notified ultrasound contrast agent developer Sonus Pharmaceuticals of Bothell, WA, that its amended new drug application for EchoGen is complete. The news came after Sonus provided the FDA with the information the agency had asked for last month regarding EchoGen’s NDA amendment filing (SCAN 10/28/98).

Sonus executives had stated that the FDA’s request for more information might delay EchoGen’s road to approval, but it appears that any delay will be insignificant in light of the FDA’s acceptance of the filing. The FDA now has up to six months, beginning Oct. 19, to review EchoGen’s NDA.