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news.The FDA has officially accepted the new drug application submitted by Titan Pharmaceuticals for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia.
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The new drug application (NDA) was submitted by Vanda Pharmaceuticals and includes data from 35 clinical trials and more than 3,000 patients treated with iloperidone. Acceptance of the NDA confirms that the application is sufficiently complete for an FDA review. Upon commercialization of iloperidone, Titan will receive a royalty of between 8% and 10% on worldwide sales.
Marc Rubin, president and CEO of Titan, said: “We are very pleased with the acceptance of the iloperidone NDA for review by the FDA. This represents further progress towards potentially providing schizophrenia patients with a meaningful therapeutic option.”