SUDA Pharmaceuticals Ltd. announced 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. SUDA has agreements for ZolpiMist in Brazil, Chile, Mexico, China, Philippines, Malaysia, Singapore with options over Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei. SUDA is in negotiations with pharmaceutical companies for other countries in South America as well as for Korea, Middle East and North Africa, UAE, Kuwait, Spain, Italy, France and Germany.