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Final decisions and reasons for NCEs, medicines and chemicals, November 2018
Scheduling medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include doravirine in Schedule 4 as follows:
Schedule 4 - New Entry
Index - New Entry
1 June 2019
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- the risks and benefits of the use of a substance:
It is a New Chemical Entity with no clinical or marketing experience in Australia. The risk-benefit requires appropriate selection of patients by the treating physician.
- the purposes for which a substance is to be used and the extent of use of a substance:
Used in the treatment of a serious infection (HIV) requiring specialised medical oversight and monitoring.
- the toxicity of a substance:
Doravirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Toxicity typical of NNRTI agents is expected. Drug interactions are also a safety concern.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Presentation and packaging consistent with the labelling requirements for prescription medicine.
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
The delegate of the Secretary proposed to amend the Poisons Standard with respect to doravirine, a new chemical entity (NCE) for a human therapeutic medicine.
Doravirine is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Section 52E(1) of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2018); and
- Advice on the place in therapy of this NCE.