Te­va re­ceives CRL for re­for­mu­lat­ed schiz­o­phre­nia drug de­vel­oped with French biotech

Though Te­va Phar­ma­ceu­ti­cals is large­ly known for its biosim­i­lars busi­ness, it still en­gages in the oc­ca­sion­al, tra­di­tion­al re­search agree­ments with small­er biotechs. But one such deal ran in­to a brick wall at the FDA late Tues­day.

Te­va and its part­ners at the French biotech Med­in­Cell re­ceived a com­plete re­sponse let­ter for their sub­cu­ta­neous schiz­o­phre­nia treat­ment, the com­pa­nies an­nounced Tues­day af­ter­noon. The pair did not pro­vide a rea­son as to why reg­u­la­tors is­sued the CRL, but Med­in­Cell not­ed in a state­ment that Te­va would be re­spon­si­ble for re­solv­ing any con­cerns.

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