11:39 AM EST - Labopharm Inc. : announces new developments on its investigational depression drug DDS-04A, a novel once-daily formulation of trazodone. The U.S. FDA is scheduled to decide on the drug on July 18. The Canadian biotech company filed its New Drug Application, or NDA, for DDS-04A last September under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. This section typically applies to reformulations of drugs that are already approved and being marketed, allowing the company to refer to existing efficacy and safety data on trazodone. Labopharm's NDA was based on data from five pivotal pharmacokinetic studies and the positive results from its North American phase III placebo controlled clinical trial, which enrolled over 400 patients. Labopharm Inc.
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