Teva Denied On LAI Risperidone But Expected To Bounce Back ‘Quickly’

Israeli Firm ‘Reviewing Its Next Steps’ And Will ‘Work Closely’ With FDA

 
• By Dean Rudge
  
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Development partners Teva and MedinCell are not licking their wounds after being denied USFDA approval for their proposed 505(b)(2) hybrid risperidone long-acting injectable product.

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Teva and MedinCell are collaborating on a 505(b)(2) risperidone • Source: Shutterstock

Teva’s attempts to break the stranglehold of Janssen’s multi-billion-dollar Invega (paliperidone) franchise and other brands in the long-acting antipsychotic market have been dealt a blow, with the US Food and Drug Administration issuing a complete response letter rejecting approval for the company and partner MedinCell’s proposed 505(b)(2) hybrid risperidone long-acting injectable product.

In a strongly worded statement, MedinCell said that it fully trusted that Teva would “remedy this quickly given the positive...

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