Radiopharmaceutical developer Palatin Technologies announced today that the Food and Drug Administration has accepted for full review the company’s biologics license application (BLA) for its LeuTech infection imaging agent.
The first indication for LeuTech is for diagnosing equivocal appendicitis, an application for which Palatin has completed phase III trials. The Princeton, NJ, company submitted the BLA for this application in November; it typically takes 10 to 12 months for the agency to review most submissions, the company said.
Palatin plans to pursue additional applications for LeuTech, and is conducting phase II clinical studies for indications such as imaging osteomyelitits. Contrast agent company Mallinckrodt of St. Louis has marketing rights to LeuTech under an agreement signed between the companies last year.
By AuntMinnie.com staff writers
February 2, 2000
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