Arch Therapeutics announced they filed a 510(k) submission to the US Food and Drug Administration for their AC5 topical gel.
Arch Therapeutics (OTCQB:ARTH) announced they filed a 510(k) submission to the US Food and Drug Administration for their AC5 topical gel.
As quoted in the press release:
If the Company’s 510(k) application is cleared by the FDA, it is expected that the AC5™ Topical Gel will be used for external wounds. “This is an important milestone for Arch,” said Terrence W. Norchi, President and CEO of Arch Therapeutics, Inc. “As previously shared, we planned to request 510(k) clearance in the middle of 2017 for the external use AC5™, which is a significant acceleration from original expectations of seeking U.S. regulatory approval through the PMA process, and we have met that goal. This achievement illustrates the ability of our team to execute on our development and regulatory strategies.”
As previously disclosed, the Company still plans to seek regulatory approval to market other AC5™ products for internal use through the PMA process. Arch will continue to concentrate resources on the rest of its development and regulatory objectives. The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018. In the interim, Arch will continue to evaluate its commercialization options and it will provide further guidance as appropriate.