Supply of bethanechol chloride (UROCARB) 10 mg tablets by Mayne Pharma International Salisbury

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On April 12, 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 product bethanechol chloride (UROCARB) 10 mg tablets [Aust R 14861], by Mayne Pharma International Salisbury, SA (“the Company”);

That does not conform with the related substances requirements of the USP 2013 monograph for Bethanechol Chloride Tablets and (for the drug substance) the USP 2013 monograph for Bethanechol Chloride.

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:

1. The consent applies until the end of July 2013.
2. The investigations into developing a test method which would ensure compliance with the official standards, described in the letter of application, will continue.
3. No other changes have been made to the product; bethanechol chloride (UROCARB) 10 mg tablets [Aust R 14861].