Posts tagged: alexza
FDA accepts Alexza ADASUVE NDA, assigns PDUFA action date
Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has accepted the ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.
Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients
Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration in response to a Complete Response Letter (CRL) received in October 2010.
Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
MOUNTAIN VIEW, Calif., Nov. 1, 2010 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it will report results for its fiscal quarter ended September 30, 2010, on Tuesday, November 9, 2010 following the close of the U.S. financial markets. As the Company recently held an investor ...
Alexza reacquires U.S. and Canadian rights for Staccato Loxapine from BLS
Alexza Pharmaceuticals, Inc. announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL, a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.
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) ...
Alexza Pharmaceuticals to Present at Jefferies 2010 Global Life Sciences Conference
MOUNTAIN VIEW, Calif. , June 3 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that company President and CEO Thomas B. King will present during the Jefferies 2010 Global Life Sciences Conference. The Alexza presentation will be on Thursday, June 10, 2010 ...
Alexza Secures $25 Million Committed Equity Financing Facility With Azimuth Opportunity, Ltd.
MOUNTAIN VIEW, Calif. , May 26 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has obtained a committed equity financing facility under which it may sell up to $25 million of its registered common stock to Azimuth Opportunity, Ltd. over a 24-month ...
Alexza Pharmaceuticals to Present at The Ninth Annual JMP Securities Research Conference
MOUNTAIN VIEW, Calif. , May 5 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that company President and CEO Thomas B. King will present during The Ninth Annual JMP Securities Research Conference. The Alexza presentation will be on Tuesday, May 11, 2010 ...