1. Generics Bulletin
  2. >>Products
  3. >>Value Added Medicines

Teva Targets Risperidone LAI In H1 2023 Following Earlier FDA Snub

505(b)(2) Hybrid Risperidone Long-Acting Injectable Given Name Uzedy

 
• By Dean Rudge

Teva maintains that the clinical data package looks sounds for it and partner MedinCell’s proposed 505(b)(2) hybrid risperidone long-acting injectable product, as the firms look to muscle in on the multi-billion-dollar LAI schizophrenia market next year.

Target
Teva is targeting a H1 2023 launch • Source: Shutterstock

Teva is optimistic of launching it and partner MedinCell’s proposed 505(b)(2) hybrid risperidone long-acting injectable product in the US by 1 July 2023, after completing re-submission of the firm’s new drug application with the US Food and Drug Administration.

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

Teva Shares Encouraging Patient Survey Data For Long-Acting Olanzapine

 
• By Adam Zamecnik

Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.

Cipla Becomes Formosa’s Latest Clobetasol Partner With 11-Country Deal

 
• By Dean Rudge

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

Amneal’s Rytary Follow-On Crexont Could Hit $500m In Sales

 
• By Dean Rudge

Amneal has spoken excitedly about its Crexont (carbidopa/levodopa) extended-release capsules as the Parkinson’s disease drug passes six months on the market.

Hyloris Celebrates Valacyclovir FDA Filing Amid Series Of Announcements

 
• By Adam Zamecnik

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.

More from Products

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.