December 18, 2017 / 1:16 PM / a month ago

BRIEF-Arch Therapeutics Withdraws 510(K) With Plans To Resubmit After Further Discussions With FDA

Dec 18 (Reuters) - Arch Therapeutics Inc:

* ARCH THERAPEUTICS WITHDRAWS 510(K) WITH PLANS TO RESUBMIT AFTER FURTHER DISCUSSIONS WITH FDA

* ARCH THERAPEUTICS INC - ‍PLANS TO SUBMIT A NEW 510(K) AS SOON AS POSSIBLE FOLLOWING FURTHER DISCUSSION WITH FDA FOR AC5 TOPICAL GEL​

* ARCH THERAPEUTICS- WITHDREW APPLICATION AFTER GETTING FDA QUESTIONS FOR WHICH ADEQUATELY COMPREHENSIVE RESPONSE COULD NOT BE PROVIDED IN REVIEW PERIOD

* ARCH THERAPEUTICS - ‍FDA REQUESTED ADDITIONAL INFORMATION FOR AC5 TOPICAL GEL THAT WAS NOT FEASIBLE TO PROVIDE WITHIN MANDATED MDUFA DEADLINES ​ Source text for Eikon: Further company coverage:

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