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Arch Therapeutics wound gel gets US FDA clearance


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Arch Therapeutics wound gel gets US FDA clearance

Arch Therapeutics Inc. said the U.S. Food and Drug Administration granted 510(k) clearance to its AC5 topical gel for wound management.

The topical dressing is indicated to manage partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and surgical wounds.

Arch Therapeutics had resubmitted its application seeking approval for AC5 topical gel. The biotechnology company said it would delay the product's commercialization until the first half of 2019.

Framingham, Mass.-based Arch Therapeutics uses a self-assembling barrier technology platform to develop approaches to stop bleeding, control leaking and manage wounds during surgery, trauma and interventional care.