Vriligy 60 mg (dapoxetine) — like other dapoxetine products such as Poxet or Priligy — is not approved by the U.S. Food and Drug Administration (FDA) for use in the United States. The FDA has never granted dapoxetine marketing approval for any strength (including 60 mg) to treat premature ejaculation or any other condition in the U.S. As a result, products like Vriligy 60 mg aren’t legally authorized for sale or prescription in the U.S. under FDA rules. Where dapoxetine is approved Although not approved by the FDA in the U.S., dapoxetine has been approved in Vriligy 60 mg other countries for the treatment of premature ejaculation, including under brand names like Priligy (30 mg and 60 mg) in parts of Europe and other regions. For example: In the European Union, Priligy (dapoxetine 30 mg and 60 mg) was evaluated and authorised for PE by EU regulators and member states. It’s also approved in countries such as Sweden, Germany, Spain, Italy, Korea, Malaysia, Philippines, Mexico, Argentina, Uruguay, and others.