Hyloris Announces Approval Of Condylox First Generic

US FDA Authorizes Podofilox Product With 180-Day CGT Exclusivity

 
• By Chloe Kent
  
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Hyloris has received US approval for its generic podofilox gel, previously referred to as HY-016.

FDA building.
Approval marks Hyloris' second in the US this year after Maxigesic IV • Source: Shutterstock

Belgian biopharma Hyloris Pharmaceuticals SA has announced that its development partner Padagis LLC has received final approval from the US Food and Drug Administration for the first generic rival to AbbVie’s Condylox (podofilox) Gel 0.5% . Podofilox gel is an antimycotic drug for the topical treatment of external genital and perianal warts.

Key takeaways:

  • Hyloris has announced the US approval of its generic podofilox gel, with commercialization by partner Padagis due to start this month

 

The product was previously referred to by Hyloris as HY-016 and is one of three high-barrier generic products in its...

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