The US Food and Drug Administration has accepted Hyloris’ new drug application for its valacyclovir oral liquid amid a flurry of recent announcements made by the Belgian firm.
The FDA set a PDUFA date of 12 October, setting up a potential milestone for the value-added medicines specialist to the second half of the year. The NDA – filed...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Generics Bulletin for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?