1. Generics Bulletin
  2. >>Products

Teva Prepares To Launch LAI Risperidone After US Approval

MedinCell-Partnered Schizophrenia Treatment Uzedy Has Now Been Approved By US FDA

 
• By Dave Wallace

Teva has indicated an imminent launch after gaining a long-awaited FDA approval for the Uzedy long-acting injectable risperidone 505(b)(2) hybrid product on which the firm has partnered with MedinCell. Pricing information has also been revealed.

FDA approved stamp logo, blue
The FDA has approved Teva and MedinCell’s LAI risperidone as Uzedy • Source: Shutterstock

Teva expects to launch its Uzedy long-acting injectable risperidone product within weeks after receiving a long-awaited US Food and Drug Administration approval for the 505(b)(2) hybrid schizophrenia treatment.

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 Products

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By Adam Zamecnik

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

More from Generics Bulletin

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."