Approval for SUDA Pharmaceuticals' ZolpiMist

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Perth-based SUDA Pharmaceuticals (ASX:SUD) has announced the TGA has approved its lead product ZolpiMist (zolpidem tartrate) for the treatment of short-term insomnia in adults.

The drug delivery company is focussed on the development of treatments delivered by oro-mucosal administration.

The company said it submitted a Marketing Authorisation Application (MAA) to the TGA for ZolpiMist in April 2019.

It subsequently decided to register a supplemental active pharmaceutical ingredient (API) supplier and final product manufacturer. This required an amendment to the TGA submission. 

SUDA said TGA approval includes the supplemental API supplier and final product manufacturer. It said this allows the company to supply the product at a more competitive supply price and allows it to potentially target additional territories.

According to CEO and managing director Dr Michael Baker, “The TGA submission was a combined effort by SUDA’s technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.”