Hyloris Celebrates Valacyclovir FDA Filing Amid Series Of Announcements

The Belgian Player Disclosed Three New Deals Through February

Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.

US Food and Drug Administration
(Shutterstock)

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

More from Value Added Medicines

Teva’s Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

 
• By 

Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

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.

How To Make The Most Of Your GGB Awards Entries

 
• By 

With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.

More from Generics Bulletin

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By 

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By 

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.