The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company’s Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK Medicines and Healthcare products Regulatory Agency questioned claims regarding Viraleze, prompting the company’s partner, LloydsPharmacy, to pause marketing of the nasal spray in the UK.
According to the TGA, Starpharma violated the Therapeutic Goods Act 1989 by promoting a therapeutic good that is not entered on the Australian Register of Therapeutic Goods; by making unauthorized claims that Viraleze stops SARS-CoV-2 infection; and by referencing astrodimer sodium, a Pharmacist Only Medicine, in advertising directed at consumers. Starpharma says that it has taken action to prevent Australian consumers from accessing the company’s web site and YouTube channel and the Viraleze product web site. Consumers outside of Australia can still access those sites.
The company said that it “takes its responsibilities and obligations for compliance with the Therapeutic Goods Act very seriously” and that it “will work closely with the TGA to resolve the current matter and how to balance the need to provide information to its shareholders about key company milestones, products and activities, with the requirements of the Act in relation to advertising in Australia.”
As it did after the questions raised by the MHRA, the company emphasized that Viraleze is registered for sale in Europe and India and said that it is “currently negotiating distribution and marketing arrangements for Viraleze in a number of countries which include India, various European countries and other international regions.”
Read the TGA press release.
Read the Starpharma press release.
