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BRIEF-Intellipharmaceutics receives complete response letter from FDA for Rexista NDA
September 25, 2017 / 11:14 AM / 3 months ago

BRIEF-Intellipharmaceutics receives complete response letter from FDA for Rexista NDA

Sept 25 (Reuters) - Intellipharmaceutics International Inc :

* Intellipharmaceutics receives complete response letter from the FDA for rexista™ NDA

* Intellipharmaceutics receives complete response letter from the fda for rexista™ NDA

* Intellipharmaceutics International Inc - ‍Intellipharmaceutics has been given one year to respond to CRL, and can request additional time if necessary

* Intellipharmaceutics international inc - ‍fda has also requested that Intellipharmaceutics submit an alternate proposed proprietary name for oxycodone ER​

* Intellipharmaceutics -do not expect additional category 2, 3 studies FDA requested will impact anticipated commercialization timeline for oxycodone ER​ Source text for Eikon: Further company coverage:

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