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FDA approves Apricus OTC anti-itch drug

The US Food and Drug Administration (FDA) has approved Apricus Bioscience to market its over-the-counter (OTC) anti-itch drug Hydrocortisone-D.

Hydrocortisone-D, which uses the company’s proprietary drug delivery technology NexACT, combines hydrocortisone with DDAIP.

The active ingredient in the cleared OTC drug, hydrocortisone, is an already approved anti-itch agent, and sold under several third party brand names like Cortizone (Chattem/Sanofi Aventis) and Cortaid (Johnson & Johnson).

Apricus chairman, president and CEO Bassam Damaj said this is the second clearance by the FDA of a drug containing Apricus Bio’s NexACT drug delivery technology, and as such, enhances their strategy of building out their OTC products division and creating a new revenue-generating portfolio for the company.