Otonomy

FDA Accepts Otonomy’s Otiprio sNDA filing for acute otitis externa

Wednesday, July 19, 2017

Otonomy, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) has been accepted for filing by the FDA and been assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.

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Otonomy acquires assets, patent rights for tinnitus program

Friday, November 1, 2013

Otonomy, a clinical stage biopharmaceutical company developing therapeutics for diseases and disorders of the inner and middle ear, has completed the acquisition of certain assets and rights to intellectual property (IP) related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec.

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Otonomy appoints Gerald Wroblewski as COO

Friday, May 27, 2011

Otonomy, a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, has appointed Gerald Wroblewski as the company’s chief operations officer.  The company has plans to initiate a phase II study for its lead drug candidate, OTO-104, in patients with Meniere’s disease and is also positioned to begin clinical trials of a second product candidate, OTO-201, by the end of 2011.

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