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Arch Therapeutics withdraws US application for medical device approval

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Arch Therapeutics withdraws US application for medical device approval

Arch Therapeutics Inc. withdrew its application seeking approval for the AC5 topical gel from the U.S. Food and Drug Administration.

The medical device is meant to stop bleeding in surgical procedures.

The company withdrew its 510(k) notification after failing to provide additional information requested by the U.S. regulator in the stipulated time.

The company plans to resubmit its application after gaining "a better understanding of the FDA's issues."

While the product is expected to be approved in 2018, its commercialization will be delayed by about one to two quarters until the first half of 2019, Arch said.