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BRIEF-AcelRx Pharma receives Complete Response Letter from the FDA for Dsuvia™ NDA
October 12, 2017 / 11:17 AM / in 5 days

BRIEF-AcelRx Pharma receives Complete Response Letter from the FDA for Dsuvia™ NDA

Oct 12 (Reuters) - Acelrx Pharmaceuticals Inc

* AcelRx Pharmaceuticals receives Complete Response Letter from the FDA for Dsuvia™ NDA

* AcelRx - ‍CRL states that FDA determined it cannot approve NDA in its present form and provides recommendations needed for resubmission​

* AcelRx Pharmaceuticals Inc - ‍confirm plans to move towards resubmission of Dsuvia NDA​

* AcelRx Pharmaceuticals Inc - ‍AcelRx ended Q3 with an estimated $67.9 million in cash and we will provide further financial updates on our Q3 earnings call​

* AcelRx Pharmaceuticals-will request a meeting with FDA to discuss topics covered in CRL

* AcelRx Pharmaceuticals Inc - ‍ received a complete response letter from FDA regarding its new drug application for Dsuvia, 30 MCG​

* AcelRx - in CRL, collection of additional data requested on at least 50 patients to assess safety of dsuvia dosed at maximum amount set in proposed labelling​

* AcelRx Pharmaceuticals Inc - ‍in CRL, FDA recommended certain changes to directions for use to address use-related errors, including dropped tablets​ Source text for Eikon: Further company coverage:

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