Pharmacyclics Gadolite oral MRI contrast agent NDA filing planned for mid-1995.
Executive Summary
PHARMACYCLICS GADOLITE ORAL MRI IMAGING AGENT MID-1995 NDA FILING is planned by the company following the completion of Phase III trials announced March 7. A preliminary review of the results of a 285-patient study of Gadolite (gadolinium alumina silicate oral suspension) shows "that the agent is well tolerated, is not absorbed, is capable of improving the interpretation of magnetic resonance imaging scans of the abdomen and pelvis and is able to reduce the need for follow-up procedures," Pharmacyclics said.
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