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

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