Tripped up by the FDA, No­var­tis says it is drop­ping out of the US race to win an OK for a block­buster Rit­ux­an ri­val

No­var­tis may have had lit­tle trou­ble get­ting an EU ap­proval for their knock­off of Roche’s Rit­ux­an last year, but they’ve reached a dead end in the US.

The phar­ma gi­ant an­nounced Fri­day that it is throw­ing in the tow­el on its cam­paign to win an OK at the FDA af­ter reg­u­la­tors de­mand­ed ad­di­tion­al in­for­ma­tion — throw­ing a mon­key wrench in­to its time­line as a host of ri­vals pressed for a green light.

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