TGA grants provisional determination to Pfizer's COVID-19 treatment
Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to the local subsidiary of US pharma giant Pfizer (NYSE: PFE) in relation to a new combination therapy containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection.
PF-07321332 is an oral antiviral treatment. It is intended to be administered in combination with low-dose ritonavir - to maintain plasma levels of PF-07321332 for the duration of the treatment.
The granting of a provisional determination means that the TGA has made a decision that Pfizer Australia is now eligible to apply for provisional registration of this treatment in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that Pfizer will submit an application for provisional registration shortly.
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