FDA Asks Hyloris For More Data On Maxigesic IV
Value Added Medicines Specialist Receives Complete Response Letter From US Agency
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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Hyloris Submits Additional Data For Maxigesic IV Filing To US FDA
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.
Hyloris Lines Up Hectic Year Of Clinical Trials And Major US Launch
Hyloris has an eventful year ahead as it plans to conduct numerous trials for products in its ever-expanding pipeline and launch Maxigesic IV in the US.
Hyloris Partner Signs To Market Maxigesic IV In Central And Eastern Europe
Hyloris’ partner AFT has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals covering nine central and eastern European countries. Meanwhile, Hyloris has also struck an in-licensing deal for a new blood phosphorus deficiency treatment.