24 April 2019 - Australian TGA approval decision expected in early 2020.

Aytu BioScience today announced the submission of ZolpiMist (zolpidem tartrate oral spray) for regulatory approval to the Australian Therapeutic Goods Administration (TGA). SUDA Pharmaceuticals, which holds the global ZolpiMist sublicense outside the U.S. and Canada, has made this submission and further disclosed that the TGA has accepted the ZolpiMist Marketing authorisation application for review and the review is underway.

Aytu BioScience previously announced its partnership with SUDA Pharmaceuticals as the licensee of ZolpiMist outside the U.S. and Canada, and SUDA already has multiple sub-licensing agreements in place around the world. This submission to the Australian TGA represents SUDA's first direct regulatory submission, and the expected review period is 255 days. Accordingly, a decision by TGA is expected in early calendar 2020.

Read Aytu BioScience press release