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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.

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Generics Bulletin reviews global regulatory developments across the world.