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.

Tell Me More Magnifying Glass
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.

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

More from Value Added Medicines

More from Products

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By 

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

Discounted Ustekinumab Biosimilars Further Dent J&J’s Q1 Stelara Sales

 

With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.

Iconovo Slims Down As It Focuses On Commercialization

 
• By 

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.