COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On October 29, 2013 the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product, chlorthalidone 25 (HYGROTON) 25 mg tablet bottle [Aust R 11035], by Link Medical Products Ltd Warriewood, NSW (“the Company”);
That do not conform with the dissolution requirements of the Unites States Pharmacopeia (USP) monograph for chlorthalidone tablets in that the test method includes a paddle speed of 100 rpm instead of the monograph paddle speed of 75 rpm.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The dissolution test method used is as provided with the Company letter, utilising a paddle speed of 100 rpm instead of the USP monograph speed of 75 rpm; and
2. The other finished product specification requirements are as provided with the Company letter and modified with the Company letter of September 10, 2013 ensuring all other requirements of the USP monograph for chlorthalidone tablets are met or exceeded; and
3. No changes other than those separately approved under subsection 9D(3) of the Act in the Company letter of October 29, 2013 have been made to the product.