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Where is Poxet 60 mg approved by FDA?
Where is Poxet 60 mg approved by FDA?
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kirazmattson
949 posts
Mar 12, 2026
2:09 AM
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Poxet?60?mg (dapoxetine) is not approved by the U.S.?Food and Drug Administration (FDA) for use in the United States. The FDA previously reviewed the active ingredient dapoxetine for treating premature ejaculation but did not grant approval after initial submissions, and it has not been approved as of now for marketing in the U.S. for any strength (including 60?mg). Regulatory Status of Dapoxetine (Poxet) United States (FDA): POXET 60 MG — the active drug in Poxet 60?mg — has not been approved by the FDA for treating premature ejaculation. An application was submitted in the mid?2000s, but the FDA issued a not?approvable letter and it has never been approved since. Europe: Dapoxetine has been approved in many European countries for premature ejaculation under brand names like Priligy (30?mg and 60?mg) following review by authorities such as the European Medicines Agency (EMA). Other Countries: Dapoxetine products, including Poxet, are approved and marketed in dozens of countries (e.g., parts of Europe, Asia, Mexico, South Korea, New Zealand) for PE treatment.
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