Part A - Final decisions on matters referred to an expert advisory committee (November 2017)
1. Advisory Committee on Medicines Scheduling (ACMS #22)
1.4 Ibutamoren
On this page: Delegate's final decision | Public submissions on the interim decision |Interim decision | Scheduling proposal
Delegate's final decision
Final decision:
The delegate's final decision is to include ibutamoren in Schedule 4 with an Appendix D (Part 5) entry as follows:
Schedule 4 - New Entry
# IBUTAMOREN.
Appendix D, Part 5 - New Entry
IBUTAMOREN.
Index - New Entry
IBUTAMOREN
cross reference: MK-677, Nutrobal
Schedule 4
Appendix D, Part 5
Implementation date: 1 June 2018
Reasons:
As no new evidence has been received to alter the interim decision for ibutamoren, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.
Public submissions on the interim decision
No public submissions were received.
Interim decision
The interim decision for ibutamoren was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.4. Ibutamoren.
Scheduling proposal
The pre-meeting scheduling proposal for ibutamoren was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.