|End-of-day quote - 01/15|
AFT Pharmaceuticals : WELCOMES US FDA COMPLETE RESPONSE LETTER
|11/09/2020 | 09:25am|
In the letter, the US regulator said an FDA Good Manufacturing Practice (GMP) inspection of the tablet production facilities - delayed due to COVID-19 related travel disruptions - was the 'only deficiency' with AFT's application.
A CRL indicates the FDA has completed its review of a new drug application. The letter covered AFT's application for prescription Maxigesic tablets, branded Combogesic in the US, for treatment of mild to moderate acute pain.
The FDA also requested minor labelling changes and asked for updated global safety data.
AFT Managing Director Dr
'This is a very pleasing result. The letter shows a prescription version of Maxigesic is approvable in the US and that AFT is well on the way to approval of its patented medicine in the US market.
'The labelling and safety data are simple to address. The GMP inspection of the manufacturing site which is located outside the US and has previously held FDA GMP approval will take longer to resolve due to present COVID19 travel bans. We will need to await lifting of these restrictions to organise the site inspection. However, a remote GMP inspection has already been requested which is an alternative solution. Presently the precise timing cannot be confirmed.'
'Talks with potential licensees are ongoing, and a positive CRL was a major endpoint, we now look forward to progressing these discussions, and the one final outstanding regulatory requirement in the coming months,'
For and on behalf of
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AFT is a growing multinational pharmaceutical business with a broad range of products, both developed itself and in-licensed from third parties. AFT's products cover all major pharmaceutical distribution channels: over-the-counter, prescription and hospital. Historically, AFT's home markets have been
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