Cystagon (cysteamine bitartrate) 150 mg capsules (Mylan/Viatris, USA) is now S19A

Jun 2
1 min read

Dear Healthcare Professional,

Shortage of CYSTAGON mercaptamine (cysteamine) (as bitartrate) 150mg capsule bottle (AUST R: 60452) and alternative supply arrangement under Section 19A of the Therapeutic Goods Act 1989 The Australian registered medicine, CYSTAGON mercaptamine (cysteamine) (as bitartrate) 150mg capsule bottle (AUST R:

60452), sponsored by Alphapharm Pty Ltd, will be in short supply from late June 2026.

Pro Pharmaceuticals Group has arranged supply of an alternative product, CYSTAGON cysteamine bitartrate (mercaptamine) 150 mg capsules (USA) on a temporary basis. This product is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31st March 2027.

For detailed information, including administration instructions and a comparison with the ARTG-listed product, please refer to the Dear Healthcare Professional (DHCP) letter approved by the TGA.

For orders or further information:

For any regulatory or pharmacovigilance enquiries, please contact: regulatory@propg.com.au

Please circulate this information to the relevant teams within your organisation.