Allergan has secured regulatory approval for an alternative product to address a Prednefrin Forte shortage in Australia.
The company confirmed to Insight it had received a Section 19A approval through the Therapeutic Goods Administration for Pred Forte prednisolone acetate 10mg/mL eye drops 5mL (UK), which it hopes will be available in late July.
Section 19A medicines do not appear on the Australian Register of Therapeutic Goods, but are approved for import and supply in Australia because:
- there is a shortage of a medicine registered in Australia; and
- the medicine is needed in the interest of public health.
Pred Forte’s approval is valid until February 2022.
It will come from the UK and is indicated for severe inflammation (non-infectious), such as acute iritis, iridocyclitis, scleritis, episcleritis, uveitis, resistant ocular allergy and inflammation following surgery (where no infectious aetiology is suspected), particularly where unusually rapid control of the inflammation is desired.
Allergan’s Prednefrin Forte product – with the active ingredients phenylephrine hydrochloride and prednisolone acetate – has not been available since February. Authorities have stated the impact on patients is “medium”.
A spokesperson for Allergan, an AbbVie company, previously confirmed Prednefrin Forte supply wouldn’t resume until early 2022. This was related to manufacturing issues.
The NSW Government’s Clinical Excellence Commission – the lead agency supporting safety improvement in the NSW health system – previously issued an alert to the state’s health professionals in public health organisations on 3 March.
The communication provided a list of potential alternative agents, as well as precautions and safety issues associated with alternative products.