The Food and Drug Administration has asked radiopharmaceutical developer Palatin Technologies for more data regarding the firm's biologics license application (BLA) for its LeuTech agent. The letter says the FDA has completed its review of the Princeton, NJ-based vendor’s clinical efficacy and safety data, but needs additional manufacturing and process validation data prior to approval, according to Palatin.
Although the manufacturing issues will affect the timing of LeuTech’s launch, Palatin plans to file an amendment as expeditiously as possible to secure final approval for the agent, according to president and CEO Dr. Carl Spana. LeuTech is a monoclonal antibody for diagnosing appendicitis in patients with equivocal symptoms, according to Palatin.
By AuntMinnie.com staff writersSeptember 28, 2000
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