Mayne Lines Up Two, But Misses Out On Myring

 
• By Aidan Fry
  
Generate a summary of this article
Listen to this article
Beta

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.

Approved by the FDA on 11 December, somewhat earlier than Mayne’s previous forecast of “early calendar year 2019”, Tolsura employs...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

SpotifyApple PodcastsWebsite

More from Value Added Medicines

  • Neuraxpharm Enters Japanese Market 1

     
    • By David Wallace

    Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.

  • Hyloris Sets Out Plans To Expand Its Pipeline

     
    • By Akriti Seth

    After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024. 

  • Awards Offers Two Weeks Of Online Networking

     
    • By David Wallace

    From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

  • Hyloris And Purna Strike Value-Added Development Deal

     
    • By David Wallace

    Value-added medicines specialist Hyloris has struck a deal worth up to €4.3m with Purna Female Healthcare to develop a treatment for vulvovaginal candidiasis that combines miconazole and domiphen bromide.

More from Products

  • For Generics, A Victory Lap – And A Warning – On Drug Shortages

    Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.

  • GB-Free-Company-The Secret to Walking More: It’s Not Counting Steps

    We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

  • Biocon And Teva Sign Up To Biosimilars Forum

    Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.