SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oromucosal drug delivery, is pleased to announce that the Therapeutics Goods Administration (TGA) has approved the registration of the Company’s lead product ZolpiMist (zolpidem tartrate) for the treatment of short-term insomnia in adults.
As outlined on 12 May 2020, SUDA had submitted a Marketing Authorisation Application (MAA) to the TGA for ZolpiMist in April 2019. SUDA, subsequent to the submission, made a strategic decision to register a supplemental active pharmaceutical ingredient (API) supplier and final product manufacturer which required an amendment to the TGA submission. Completion of the TGA review was expected Q4 2020.
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