• Chile approval achieved for SUDA’s ZolpiMist®
• This approval enables ZolpiMist to be marketed in Chile by SUDA’s partner, Teva Pharmaceuticals
• This is the first of Teva’s territories to achieve approval
• This approval supports corresponding submissions in additional territories
PERTH, AUSTRALIA – 21 October 2021: SUDA Pharmaceuticals Ltd (ASX: SUD), a biotechnology company focused on developing therapies to treat cancer and conditions that affect the central nervous system, is pleased to announce that the Ministry of Health, Chile, has approved the registration of the Company’s lead product ZolpiMist (zolpidem tartrate) by Teva Pharmaceuticals for the treatment of short-term insomnia in adults.
SUDA’s partner, Teva Pharmaceuticals, submitted a Marketing Authorisation Application (MAA) with the new supplemental API supplier and the Australian final product manufacturer to the Chilean authority for ZolpiMist in May 2021. Approval was granted significantly sooner than the expected date of April 2022.
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