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FDA Rejects Loxapine for Approval

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FDA Rejects Loxapine for Approval

Post  Admin on Sat May 05, 2012 10:36 am

FDA Rejects Loxapine for Approval

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) saying that the new drug application for loxapine inhalation powder (Adasuve, Alexza Pharmaceuticals, Inc) is not ready for approval in its current form.

According to a company news release, the deficiencies are medical device specific and readily addressable. Company officials plan to meet with the FDA as soon as practical in order to gain a "better understanding" of the specific problems and resolve remaining issues in a timely manner.

In past: Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE(TM) (Staccato® loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania.

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