The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.
Belgian value-added medicines specialist Hyloris has announced that the US Food and Drug Administration has set an earlier than expected prescription drug user fee act date of 30 June 2022 for the firm’s 505(b)(2) new drug application for its Maxigesic IV (paracetamol/ibuprofen) 1,000mg/300mg intravenous analgesic for treating post-operative pain.
The 30 June 2022 date was “ahead of the August to September 2022 timeframe initially expected,” Hyloris indicated
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
