Hyloris Lines Up FDA Filing For Valacyclovir Oral Suspension

Also Adds Rights In New Markets As Clinical Trial Delivers Positive Results

As Hyloris revealed positive clinical trial results for valacyclovir oral suspension, the firm also disclosed plans for a US filing by the end of 2024 as well as expanded rights to the product in additional markets.

Sign outside of FDA's headquarters in White Oak, MD
Hyloris is planning an FDA filing by the end of the year • Source: Alamy

Belgian value added medicines specialist Hyloris Pharmaceuticals has set out the next steps for its proprietary oral suspension formulation of valacyclovir after the product produced positive trial results in a pivotal clinical study.

“The additional pivotal clinical study demonstrates comparable relative bioavailability to Valtrex tablets, as sold in the US, under fasted conditions,”...

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