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FDA Rejects Loxapine for Approval - Medscape
RTT NewsFDA Rejects Loxapine for ApprovalMedscapeMay 5, 2012 — 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 .
FDA again rejects Alexza's Adasuve, citing manufacturing deficiencies - The Pharma Letter
FDA again rejects Alexza's Adasuve, citing manufacturing deficienciesThe Pharma LetterLoxapine already is approved in a capsule form for long-term treatment of schizophrenia, but Alexza is seeking approval for an inhaled form that would be administered for acute agitation associated with schizophrenia or bipolar I disorder in adults.
Benzinga's Microcap Movers for Friday May 4, 2012 - Benzinga
Benzinga's Microcap Movers for Friday May 4, 2012BenzingaAlexza Pharmaceuticals announced Thursday that it had received a Complete Response Letter from the US Food and Drug Administration regarding its New Drug Application for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg.
Biotech Industry Hotbed of Merger & Acquisition Speculation - MarketWatch (press release)
Biotech Industry Hotbed of Merger & Acquisition SpeculationMarketWatch (press release)The company recently received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application for ADASUVE (loxapine) inhalation powder.