Ann: US patent issued for DEP cabazitaxel nanoparticle, page-33

https://www.tga.gov.au/sites/defaul...ms-joint-accs-acms-meetings-november-2021.pdf



One can probably deduce that the Viraleze application is in at the TGA, however the dates for ‘consultation’ aren’t until November 7th so I am not sure I would expect a TGA Approval anytime soon ?

1 Proposed amendments referred for scheduling advice to ACMS #35

1.1 Astodrimer sodium

Proposal

The applicant has proposed amendment of the existing Appendix F and Appendix H entries for astodrimer to include new warning statements for preventative use, and to remove existing restrictions on advertising for preparations containing the substance.

CAS Number:
676271-69-5

Alternative names
2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino- hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt; SPL7013

Applicant
Private applicant

Current scheduling
Astodrimer sodium is currently listed in Schedule 3 of the Poisons Standard:

Schedule 3
ASTODRIMER SODIUM except in a condom lubricant.

Index
ASTODRIMER SODIUM


Schedule 3 Appendix F, Part 3 Appendix H
It is also included under the entries for ASTODRIMER SODIUM in Appendix F and

Appendix H as follows:

Appendix F, Part 3 WARNING STATEMENTS
64 See a doctor (or) (dentist) if no better after (Insert number of days as per