Latest MAOI updates
by Dr Ken Gillman
The situation in different countries around the world is very different for all sorts of reasons so remember that these comments are international and may not always apply to particular localities.
It is likely that much of the comment here applies not just to Nardil, but also to many other less-used out of patent drugs of all kinds, not just psychotropics. Thus, this is an illustration of the old quotation from John Donne ‘No man is an island…’. Everyone is in this together.
This problem is likely to affect everybody everywhere, sooner or later, just like the Covid virus.
I have received information from all sorts of people all over the world and will try to condense here my deductions and thoughts about what is going on.
We continue to work on this international Nardil shortage problem, if you have any updated information please let us know by email
Individuals can import up to 3 months for personal use (with a prescription) under the Special Access Scheme for TGA contact - ph 1800 020 653. Click here for more information about special access scheme
|Product details||Supply Impact Dates||Further Details|
NARDIL phenelzine 15mg (as sulfate) tablet bottle
|Deletion from market:
02 Apr 2020
TGA Management Actions:
(Sourced from: Therapeutic Goods Administration, Queensland Health https://apps.tga.gov.au/Prod/msi/Search/Details/phenelzine-sulfate)
Seigfried produce the API (active pharmaceutical ingredient) and their director Andrew Lamb says:
- we currently have no intention to stop manufacture of this API and will continue to supply into existing markets as long as our customers' demand remains, .. Depending on the market demand, we will produce Phenelzine Sulfate every 12-18 months. … We will work proactively with Kyowa Kirin and with their nominated Contract Manufacturer(s) to supply API from the 2020 campaign and to plan the next production campaign after 2020.
- there are a very large number of factors which influence the overall cost of a drug dose, including economy of scale, process complexity, raw materials costs, storage and distribution costs, R&D costs, etc.
- I am confident that our partners are ready to resupply the UK market as soon as possible (initially from material transferred from Recipharm and then from the new Siegfried supply). I am also sure that each party is in contact with the right people to allow timely planning for future supply beyond this year.
Kyowa Kirin U.K. were using a contractor, Recipharm U.K., to manufacture* Nardil brand and their source of the API was from Siegfried CH .
*In the sense I think ‘manufacture’ means to make it up into tablets with the appropriate colourings and excipients, but I’m willing to be corrected on this detail
Recipharm seems to have been ‘closed down’ by the U.K. MHRA due to cross contamination. Kyowa Kirin U.K. are as far as I understand it a mere intermediary in this process since they don’t produce the API and they contract out the production of the tablets.
|Alium Medical||Tel: 020 8238 6770
|Chemys Limited||Tel: 02085008497
|Clinigen Group PLC||Tel: 01932 824100
|Durbin PLC||Tel: 0208 869 6555
|Ethigen Ltd||Tel: 0800 019 7100
|Mawdsley-Brooks & Co||Tel: 01302 553000
|Target Healthcare UK Limited||Tel: 08456 180036
|Thistle Pharma Limited||Tel: 0800 169 9765
|WEP Clinical||Tel: 0208 004 8185
(Sourced from Pharmacy Business https://www.pharmacy.biz/nardil-15mg-tablets-likely-to-remain-out-of-stock-this-year/)
Far as I can ascertain there has been no major supply issue in the USA even if some people have had difficulty getting supplies at one time or another there has still been supply available somewhere. The information below has been received from the FDA.
Labeling for most FDA approved drugs may often be found on CDER's page at DRUGS @ FDA:
‘We take concerns about drug treatments for depression and other psychiatric conditions very seriously.
FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage. However, as a regulatory agency, FDA cannot require firms to increase production or to continue making a particular product or active pharmaceutical ingredient (API) if they are not willing to do so. Please understand that this is because FDA does not have control over firms’ business decisions.
As noted by FDA’s Drug Shortages Staff in an email to Mr. Johnston, in the U.S., phenelzine supply is currently available from an approved manufacturer, Lupin Pharmaceuticals. If your patients or anyone you know is having issues with obtaining supply of phenelzine, please contactDrugShortages@fda.hhs.gov.
In terms of inspections: as noted on the COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process page, most foreign and domestic surveillance facility inspections are currently postponed. Only inspections deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.
GoodRX is not an app in the Apple store, but it is accessible through a website:
We have 1,500 packs of Marplan that can be initially shipped: Each containing 56 tablets (10 mg).
The issue is that we are only in a position to deliver packs with Danish text.
Although we do have full English translation of both Label, SPC and the Patient Insert Leaflet.
Another good news is that we are now 99% sure that Medilink is in a position to deliver a second round of Marplan by end of August. From August Medilink would be in position to deliver whatever demand needed.
Therefore, the 1,500 packs would correspond to 500-700 patients, that can be treated with an MAO-inhibitor right now.
No MAOis available.
It is possible to import TCP from Germany via Switzerland but it is very expensive (about 250 dollars/month for 30 mg/day dosage).
No MAOis available.
Expensive and long import procedures required
India based Lupin. They continue listing Phenelzine on their website. They inherited Phenelzine after buying Somerset Pharmaceuticals (the developer of EMSAM) which had bought Nardil from Pfizer.