THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 8 2013 the delegate of the Secretary of the Department of Health and Ageing 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 products:
- ondansetron (AURO-ONDANSETRON ODT 4) 4 mg orally disintegrating tablets blister pack [AUST R 196808]
- ondansetron (AURO-ONDANSETRON ODT 8) 8 mg orally disintegrating tablet blister pack [AUST R 196806]
- ondansetron (ZILFOJIM ODT 4) 4 mg orally disintegrating tablet blister pack [AUST R 196804]
- ondansetron (ZILFOJIM ODT 8) 8 mg orally disintegrating tablet blister pack [AUST R 196809]
- ondansetron (ONDANSETRON PFIZER ODT) 4 mg orally disintegrating tablet blister pack [AUST R 196807]
- ondansetron (ONDANSETRON PFIZER ODT) 8 mg orally disintegrating tablet blister pack [AUST R 196805]
By Aurobindo Pharma Australia Pty Ltd, Macquarie Park, NSW (“the Company”);
That do not conform with the United States Pharmacopeia Monograph for Ondansetron Orally Disintegrating Tablets in that the products do not comply with the disintegration requirements of not more than 10 seconds.
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 products conform to the disintegration test that is described in the application for registration of the products from the Company with a disintegration requirement of not more than 60 seconds.