Teva Denied On LAI Risperidone But Expected To Bounce Back ‘Quickly’
Israeli Firm ‘Reviewing Its Next Steps’ And Will ‘Work Closely’ With FDA
Executive Summary
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 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.
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