Posts tagged: loxapine
Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
MOUNTAIN VIEW, Calif., Oct. 19 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL ("BLS"), a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE and TSX: VRX) ("Valeant"). AZ-004 is ...
Alexza Pharmaceuticals Receives Complete Response Letter For AZ-004 (Staccato® Loxapine) NDA
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. A ...
Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
MISSISSAUGA, Ontario, Oct. 11 /- Valeant Pharmaceuticals International, Inc. (NYSE: VRX ) (TSX: VRX) announced today that Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 ...
Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
MOUNTAIN VIEW, Calif., Oct. 11 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) ...
Staccato(R) Loxapine (AZ-004) Reduced Signs and Symptoms of Agitation as Early as Ten Minutes After Dosing in Patients with Schizophrenia or Bipolar Disorder
NEW ORLEANS , May 26 /- Results of clinical studies in patients with schizophrenia or bipolar disorder demonstrated that Staccato® loxapine (AZ-004) reduced agitation in patients, regardless of the level of agitation at baseline. Improvement in agitation levels were observed as early as 10 minutes after dosing on ...
Alexza Announces AZ-004 (Staccato(R) Loxapine) PDUFA Goal Date of October 11, 2010
MOUNTAIN VIEW, Calif. , Feb. 11 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010 . ...
Alexza and Biovail Form Collaboration to Develop and Commercialize AZ-004 (Staccato(R) Loxapine) in North America
MOUNTAIN VIEW, Calif. , Feb. 10 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF ), to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and ...
Alexza Announces Submission Of AZ-004 (Staccato(R) Loxapine) NDA
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND ...
Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
MOUNTAIN VIEW, Calif., Sept. 14 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) today announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache. Both AZ-104 dose groups trended towards statistical significance, but the study did not meet ...