1. Generics Bulletin

Mayne Lines Up Two, But Misses Out On Myring

 
• By Aidan Fry

Mayne Pharma intends in January to introduce novel formulations of itraconazole and halobetasol in the US; but the Australian firm has been hit in its attempt to bring the Myring generic to the US market.

Itraconazole
Mayne Pharma will soon launch a reformulation of itraconazole in the US • Source: Shutterstock

Mayne Pharma plans during January 2019 to launch both its Tolsura (itraconazole) 65mg capsules and its Lexette (halobetasol) 0.05% foam in the US. But the Australian company’s move to bring the Myring (etonogestrel/ethinylestradiol) generic of Merck & Co’s NuvaRing contraceptive to US consumers has been dealt a blow after the US Food and Drug Administration (FDA) issued a complete response letter (CRL), Mayne’s development partner Mithra has revealed.

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
Start Free Trial

Already a subscriber?

More from Value Added Medicines

More from Products

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By Dave Wallace

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

 
• By Urtė Fultinavičiūtė

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 Dave Wallace

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.