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FDA Testosterone Approval

Meaning

FDA Testosterone Approval refers to the official authorization granted by the U.S. Food and Drug Administration for specific testosterone products to be legally marketed and prescribed for defined medical indications within the United States. This rigorous regulatory process ensures that the drug is safe and effective for its intended use, which is currently limited to men with classic hypogonadism confirmed by both symptoms and consistently low serum testosterone levels. The approval dictates the formulation, labeling, manufacturing standards, and the required risk management strategies for the medication. This oversight is paramount for patient safety.