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Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

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1.13 Obeticholic acid

New Chemical Entities - medicines for human therapeutic use

1.13 Obeticholic acid

Delegate's final decision
Final decision:

The delegate's final decision is to amend the Poisons Standard to include obeticholic acid in Schedule 4 as follows:

Schedule 4 - New Entry

OBETICHOLIC ACID.

Implementation date: 1 June 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance
    • Obeticholic acid is a new chemical entity with no clinical or marketing experience in Australia.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • Obeticholic acid is to be used to treat the serious medical condition of primary biliary cirrhosis.
  3. the toxicity of a substance
    • Obeticholic acid has potential for toxicity in overdose.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • The dose may require adjustment during the course of treatment.
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to obeticholic acid.

Scheduling status

Obeticholic acid is not specifically scheduled in the Poisons Standard.

Obeticholic acid derivatives, chenodeoxycholic acid, cholic acid, deoxycholic acid and ursodeoxycholic acid are in Schedule 4 of the Poisons Standard.

Delegate's consideration

The delegate considered the following in regards to this scheduling:

  • Advice on the place in therapy of this medicine;
  • Scheduling Policy Framework (SPF 2018); and
  • Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

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