Alexza's Inhaled Antipsychotic To Get Indication-Limiting REMS
This article was originally published in The Pink Sheet Daily
Executive SummaryFirm's proposed risk management plan may exclude patients with COPD or asthma. The application for AZ-004 is expected to be resubmitted by July, with an advisory committee likely by year end.
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Firm has responded to a second “complete response” letter from FDA and to questions from EU regulators regarding its proposed inhalation formulation of antipsychotic loxapine.