Malegra 100 mg is not FDA-approved as a brand-name product in the United States. Here's the distinction: The active ingredient, Sildenafil, is FDA-approved for treating Erectile dysfunction under products such as Viagra and FDA-approved generic sildenafil. Malegra 100 mg is a brand manufactured in India (commonly by Sunrise Remedies) and is marketed in various countries, but it does not have FDA approval as a branded product for sale in the U.S. If you are in India, availability and legality are governed by Indian drug regulators rather than the U.S. FDA. Even so, it should be obtained from a licensed pharmacy and used under the guidance of a healthcare professional because sildenafil can interact with certain medications (especially nitrates) and may not be appropriate for everyone.