Palatin Technologies has moved a step closer to Food and Drug Administration clearance for its LeuTech infection imaging radiopharmaceutical. The Princeton, NJ–based firm announced that the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) has found LeuTech to be safe and effective for use in diagnosing appendicitis in patients with equivocal signs and symptoms, and that clinical data support the agent in managing these patients.
The FDA will make its final decision based on a full review of LeuTech's biologics license application (BLA) and a review of the MIDAC recommendation. Palatin and the FDA have agreed that any remaining issues in the BLA can be resolved in the next two to three months, the company said.
By AuntMinnie.com staff writersJuly 11, 2000
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