New treatment options approved


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New medicine options approved after problems hit supply of depression treatments 

The Therapeutic Goods Administration has approved new overseas options after problems were revealed regarding the availability of a couple of depression treatments – Nardil and Parnate.

Two sponsors have been authorised to supply overseas-registered brands of phenelzine. These will replace Nardil, which was announced earlier in the year to be ceasing production.

The overseas-registered brand of phenelzine is named Phenelzine Sulfate USP 15 mg tablets (Lupin Pharmaceuticals). The two Section 19A approved sponsors are:

  • Barwon Pharma Pty Ltd (0427 902599)
  • Generic Health Pty Ltd (03 9809 7900)

However, the TGA is also reminding prescribers that, “due to the uncertainty of ongoing supply of phenelzine”, they should not initiate any new patients on phenelzine treatment. Supply of phenelzine has been a global issue, it said.

The new product is also not currently PBS listed, the regulator added.

Meanwhile, the TGA has also authorised the supply of an overseas-registered brand of tranylcypromine (Parnate) to address an expected shortage of the current Australian-registered product in late 2020.

It’s current Australian supplier, Amdipharm Mercury (Australia) has notified the TGA that Parnate 10 mg tablets will be in “short supply from 1 November 2020 to 7 December 2020 due to manufacturing issues”.

Amdipharm has now been authorised to supply an overseas-registered brand of tranylcypromine. This Section 19A product can be PBS subsidised, the TGA said.

While stock of the Australian-registered and overseas-registered products are expected to be available during the period of the shortage, Amdipharm says it is “reserving an emergency supply of tranylcypromine for patients unable to access the medicine through their pharmacy”.

Pharmacists are advised to contact Amdipharm on 0294316333 or 1800 627 680 to enquire about access to this emergency supply.

Additionally, “dispensing limits of one month’s supply at the prescribed dose will help to ensure equitable access to the medicine,” the TGA said.

“These limits have been in place for certain prescription medicines since March 2020 to prevent panic-buying or stockpiling, which can cause supply disruptions that can affect consumers’ access to medicines”.

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