Why is fusidic acid not available in the USA? Understanding the Regulatory and Market Barriers
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4 min read
Despite being used worldwide for over 60 years to treat staphylococcal infections, fusidic acid has never gained FDA approval for general marketing in the United States. The reasons why fusidic acid is not available in the USA are complex, involving regulatory statutes, market exclusivity issues, and the existence of competing US-approved alternatives.