Important antibiotic available again

Finally, Ace can report that she has solved all shortage issues around phentecillin. Making Broxil® available again - for the long term!

A lot has been done to secure the full supply chain to avoid shortages in the future.

Ace has been working on a solution for the shortage and the supply problems of the active ingredient for more than a year.

Broxil is an "old" product, with its registration in the Netherlands dating back to the 1960s. Back then, narrow-spectrum penicillins were big business. All changed when broad-spectrum antibiotics became available. Physicians and patients quickly adopted these to find out much later that there was a downside too: antibiotic resistence as a result of (too) intensive use of these broad-spectrum agents.

Nowadays, there is a strong preference for using narrow-spectrum penicillins where possible. By this time, unfortunately, most dossiers/products had been revoked from the markets as there was hardly any demand any more.

The registration of Broxil in the Netherlands was the only one remaining for pheneticillin. Previous Marketing Authorisation Holder (MAH) had tried to revoke the dossier early 2000 but the Dutch Medicines Evaluation Board had denied it. They suggested to find a new (MAH) which they eventually found in Ace.

However, as a result of the diminishing demand for the product, other actors in the supply chain had stopped their production as well. Already in 2015, Ace realised that there was only sufficient active ingredient available to last until 2017. A long search for a new manufacturer of the material (and all 12 intermediates) was started.

Ace succeeded in finding a new manufacturer in time, but had setback after setback in the production and realisation of the dossier according to the new standards. Finally by September 2018 the first batches of Broxil capsules were ready, soon to be followed by the powder for oral suspension. The approval of the MEB followed two months later, making Broxil available again!