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Hyloris Submits Additional Data For Maxigesic IV Filing To US FDA

Firm Received Pushback From FDA On Product’s Packaging

 
• By Chloe Kent

Hyloris has submitted additional data to the US Food and Drug Administration about its value-added analgesic Maxigesic IV, following enquiries about potential extractable and leachable compounds expected to be present in the product due to the packaging.

Entrance to FDA headquarters in Maryland
The FDA had additional questions about the vial and stopper of the Maxigesic IV packaging • Source: Alamy

Belgian value-added medicines firm Hyloris and its development partner AFT Pharmaceuticals have submitted additional data to the US Food and Drug Administration regarding its 505(b)(2) hybrid application for Maxigesic IV (paracetamol/ibuprofen) 1,000mg/300mg. The application was knocked back by the FDA last year when it requested additional information about the dual mode-of-action intravenous pain treatment.

The submission of Hyloris’ “additional extractable & leachable data set” followed a complete response letter received in July 2022 regarding the FDA’s assessment of the primary packaging, “in essence

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