Rovi’s Value-Added US Risperidone Gets New Goal Date, Teva Ruled Out As Partner

Follows Teva’s Recent Launch Of Rovi’s Xeplion Generic In Spain

Spain’s Laboratorios Farmacéuticos Rovi has a firm date to remedy issues observed in its application for a hybrid version of risperidone, developed using Rovi’s proprietary ISM drug-release technology platform.

• Source: Shutterstock

Laboratorios Farmaceúticos Rovi’s Risvan (risperidone) once-monthly injectable, a proposed 505(b)(2) hybrid version of Janssen-Cilag’s Risperdal tablets, has been handed a new US Food and Drug Administration user fee goal date after the Spanish player submitted final responses to a second complete response letter denying its approval.

But as it continues to push through Risvan, Rovi has confirmed that Teva is not in consideration

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

More from Value Added Medicines

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

Iconovo Slims Down As It Focuses On Commercialization

 
• By 

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.

How To Make The Most Of Your GGB Awards Entries

 
• By 

With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.

Teva Shares Encouraging Patient Survey Data For Long-Acting Olanzapine

 
• By 

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.

More from Products

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By 

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By 

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.