FDA re­quests ad­di­tion­al time for Flex­ion's sN­DA; Genen­tech re­leas­es da­ta for PhI­II study of Rit­ux­an

→ In 2017, the FDA green­light­ed Flex­ion Ther­a­peu­tics‘ in­tra-ar­tic­u­lar ther­a­py, Zil­ret­ta, de­signed as a treat­ment for os­teoarthri­tis-re­lat­ed knee pain. Now, two years lat­er, the com­pa­ny has an­nounced that the FDA needs ad­di­tion­al time to com­plete the re­view of its sup­ple­men­tal NDA for Zil­ret­ta. The an­tic­i­pat­ed PDU­FA date was set for to­day. Al­though the FDA has not pro­vid­ed a new ac­tion date, Flex­ion says they were in­formed that the re­view should be com­plet­ed in the com­ing weeks. No ad­di­tion­al clin­i­cal da­ta has been re­quest­ed by the FDA.

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