News
FDA raises deficiencies in the NDA for AXS 05 a proposed treatment for major depressive disorder.-Axsome Therapeutics
Axsome Therapeutics Inc. in its second quarter statement said the FDA has raised deficiencies related to the company's AXS-05 new drug application that could delay approval of the proposed treatment of major depressive disorder.
Axsome said the FDA recently notified the company that it had found unspecified deficiencies that currently preclude the discussion of labeling and post-marketing requirements and commitments. Axsome based its submission on phase II and phase III clinical trials that linked AXS-05, a combination of the active ingredient in GlaxoSmithKline’s Wellbutrin and a cough medicine, to improvements in depressive symptoms in patients with major depressive disorder.
Condition: Depression
Type: drug
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