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FDA Asks Hyloris For More Data On Maxigesic IV

Value Added Medicines Specialist Receives Complete Response Letter From US Agency

 
• By Dave Wallace

Hyloris has received a complete response letter from the US FDA asking for more information on its 505(b)(2) hybrid application for its Maxigesic IV intravenous analgesic for treating post-operative pain.

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The FDA has asked for more information as it examines Maxigesic IV • Source: Shutterstock

Value-added medicines specialist Hyloris has seen its 505(b)(2) hybrid application for Maxigesic IV (paracetamol/ibuprofen) 1,000mg/300mg knocked back by the US Food and Drug Administration, which has issued a complete response letter asking for more information on the novel intravenous analgesic for treating post-operative pain.

Noting that “the FDA has only requested additional data on one remaining topic,” the Belgian company said “we believe, along with our partners at [development partner] AFT Pharmaceuticals, that generating...

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