Suda provides ZolpiMist regulatory update

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SUDA Pharmaceuticals (ASX:SUD) has announced that the TGA has accepted for review the Marketing Authorisation Application (MAA) for ZolpiMist Oral spray for the treatment of insomnia.

The company said, based on a submission earlier this year, the TGA has advised that the filing has been found to have passed the preliminary assessment and it has accepted the dossier for full a 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.

The company also said 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.