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Challenge: The website had minor errors affecting conversion rates

However, because this therapy is compounded and not formally studied as a fixed combination, its safety and efficacy rely on extrapolation from each components profile and the clinicians expertise

This lack of FDA approval means they haven't undergone the rigorous testing for safety, efficacy, and quality that regulated medications do

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However, generic manufacturers for 4 of the 10 products submitted paragraph IV challenges seeking FDA approval prior to brand-name patent expiration