AFT Pharmaceuticals (NZX.AFT, ASX.AFP) welcomes US FDA Complete Response Letter

Monday 9th November 2020

AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces it has received a US Food and Drug Administration (FDA) complete response letter (CRL) covering its application for the approval of a tablet version of its Maxigesic® pain relief medication.

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.

AFT Managing Director Dr Hartley Atkinson said the CRL indicated AFT had cleared a significant hurdle on its path towards the commercialisation of the Maxigesic pain relief family of medicines in the world’s largest pharmaceutical market.

“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.

Dr Atkinson said it was too early to say when the medicine would be approved for sale in the US. In addition to final approval from the FDA, AFT still needed to licence the medication to a distributor.

See the links below for more details:

AFT welcomes US FDA Complete Response Letter

Source: AFT Pharmaceuticals Limited

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