Teva Denied On LAI Risperidone But Expected To Bounce Back ‘Quickly’
Israeli Firm ‘Reviewing Its Next Steps’ And Will ‘Work Closely’ With FDA
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.
Teva acknowledged that it was “not independent of the macro environment in the US,” as it saw another significant drop off for its North America generics business amid a lack of new launches. The Israeli giant took the unusual step of singling out a complex generic asset – its proposed generic to Eli Lilly’s Forteo – as “the most important” potential launch for its 2022 top line.
Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker