Malegra DXT Plus is not an FDA‑approved medication. Medications that combine sildenafil (for erectile dysfunction) with duloxetine (for premature ejaculation) like Malegra DXT Plus are not approved by the U.S. Food and Drug Administration (FDA) as a combined therapy for ED and PE. Most of these combination products are manufactured and sold in markets outside the U.S. (often India or other countries) without formal FDA evaluation for safety, effectiveness, or quality in the United States. The FDA strictly regulates which drugs are approved and marketed in the U.S. based on clinical trial evidence and review. While sildenafil alone (the active ingredient in Viagra) is FDA‑approved for erectile dysfunction, the combination products like Malegra DXT Plus haven’t gone through that approval process for their combined use. If you’re considering using Malegra DXT Plus or a similar product, it’s safest to talk with a licensed healthcare provider so they can recommend treatments that are FDA‑approved and appropriate for your health situation.