Zolpimist TGA

Well 255 days (plus weekend) brings us to about today. So perhaps TGA may wish to inform Suda and Suda inform the market of the outcome. This one should be mighty beneficial to the global zolpi programme with alternative producer of the product, deals and previous deal milestones all supposedly pegged to application and subsequent approval.

PERTH, AUSTRALIA – 4 April 2019: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that that the Australian Therapeutic Goods Administration (TGA) has accepted for review the Marketing Authorisation Application (MAA) for ZolpiMist Oral spray for the treatment of insomnia.In early 2019, SUDA made a submission to the TGA and based on that submission the TGA has advised that the filing has been found to have passed preliminary assessment and the TGA has accepted the dossier for full evaluation. The evaluation process involves a number of stages and the TGA now has 255 days to complete its review and provide an opinion, including potential approval, of the ZolpiMist Marketing Authorisation.