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Is Malegra FXT Plus approved by the FDA?
Is Malegra FXT Plus approved by the FDA?
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cliffordfosterr
Guest
Jun 16, 2025
4:00 AM
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No, Malegra FXT Plus is not approved by the U.S. Food and Drug Administration (FDA). This combination medication, manufactured by Sunrise Remedies, contains 100 mg of sildenafil citrate and 60 mg of fluoxetine. Sildenafil is FDA-approved for erectile dysfunction (ED), and fluoxetine is FDA-approved for depression and certain other conditions. However, the specific combination of these two drugs in Malegra FXT Plus has not undergone the FDA's rigorous approval process for any indication.
While individual components have FDA approval for other uses, their combination in Malegra FXT Plus is considered off-label. Off-label use refers to prescribing a drug for a condition or in a manner not approved by the FDA. This means that while healthcare providers may prescribe Malegra FXT Plus, it lacks FDA endorsement for treating ED and premature ejaculation.
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davidjohn
Guest
Jun 16, 2025
4:01 AM
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