Av­enue Ther­a­peu­tics lands an FDA ad­comm for trou­bled flag­ship drug; FDA ap­proves eye in­jec­tion treat­ment for flu­id buildup

In­tra­venous tra­madol-fo­cused Av­enue Ther­a­peu­tics may not be out of the game just yet.

Af­ter re­ceiv­ing two CRLs for their drug, Av­enue an­nounced to­day that it has re­ceived a writ­ten in­ter­im re­sponse from the FDA’s Of­fice of New Drugs that reg­u­la­tors will hold an ad­comm to reach a de­ci­sion on a for­mal dis­pute res­o­lu­tion re­quest filed by Av­enue back in Ju­ly.

This oc­curred af­ter the FDA sent Av­enue the sec­ond CRL for their drug, an in­tra­venous form of syn­thet­ic opi­oid tra­madol.

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