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
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 EchoGens NDA amendment filing (SCAN 10/28/98).
Sonus executives had stated that the FDAs request for more information might delay EchoGens road to approval, but it appears that any delay will be insignificant in light of the FDAs acceptance of the filing. The FDA now has up to six months, beginning Oct. 19, to review EchoGens NDA.