Vilitra 60 mg is not FDA-approved in the United States. While the active ingredient in Vilitra — Vardenafil — is FDA-approved and available in medications like Levitra (a brand name version of Vardenafil), Vilitra is typically marketed as a generic version of Levitra, often manufactured in countries outside of the U.S. Key Points: Vardenafil (the active ingredient): The FDA has approved Vardenafil under the brand name Levitra for the treatment of erectile dysfunction (ED). It is also available in generic forms in the U.S. Vilitra: Vilitra is often manufactured and sold in countries like India, and while it contains the same active ingredient, it may not be FDA-approved in the U.S. or other countries with strict pharmaceutical regulations. Regulatory Status: Because Vilitra 60 mg is considered a generic or non-branded version of Vardenafil, it may not meet the FDA’s specific standards for approval in the U.S. Even though it is sold online or in other countries, it's important to be cautious when purchasing medications not approved by the FDA, as their quality and safety standards may not be the same. Why It Matters: FDA approval means that a medication has undergone rigorous testing for safety, efficacy, and quality control within the U.S. If you are considering using Vilitra 60 mg or any non-FDA-approved medication, it is essential to consult a healthcare professional to weigh the potential risks and benefits. If you're interested in using Vardenafil or Levitra in the U.S., it's safest to use the FDA-approved version or a generic version that has been cleared for use.