The APVMA (Australian Pesticides and Veterinary Medicines Authority) has evaluated the chemistry aspects of active constituent fluazaindolizine (physico-chemical properties, stability, identification, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.
The APVMA has considered the toxicological aspects of fluazaindolizine, and concluded that there are no toxicological concerns to the approval of this active constituent.
The ADI for fluazaindolizine was established at 0.4 mg/kg bw/day based on a NOAEL of 36 mg/kg bw/d in 3 and 12 month dietary study in dogs, while the ARfD was established at 1.3 mg/kg bw/day based on a NOAEL of 125 mg/kg bw/d in an acute oral neurotoxicity study in rats, and using a default 100-fold uncertainty factor for extrapolation from laboratory animals to humans and to take account of differences in human responses in both cases.
The Scheduling Delegate has made a final decision to include fluazaindolizine in Schedule 6 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) except when included in Schedule 5, for preparations containing 50% or less of fluazaindolizine, with a date of effect of 1 February 2021.
On the basis of the data provided, and the toxicological assessment, it is proposed that the following active constituent standard be established for fluazaindolizine:
|
Constituent |
Level |
|
Fluazaindolizine |
Minimum purity 961 g/kg |
Impurities of toxicological significance are not expected to occur in fluazaindolizine as a result of the raw materials and the synthetic route used.
The APVMA considers that the toxicological aspects of fluazaindazolidine allow it to be satisfied with respect to the safety criteria.
In accordance with section 12 of the Agvet Code, the APVMA has invited any person to submit a relevant written submission as to whether fluazaindolizine should be approved. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met and should state the grounds on which they are based. Submissions must be received by the APVMA within 28 days of the date of this notice i.e. July 14.th
(Source: APVMA)
