Is Duratia 30 mg FDA approved?

Duratia 30 mg contains dapoxetine, which is a medication primarily used to treat premature ejaculation (PE) in men. It is a selective serotonin reuptake inhibitor (SSRI), which works by increasing the levels of serotonin in the brain to help delay ejaculation. FDA Approval Status of Duratia (Dapoxetine) As of now, dapoxetine (the active ingredient in Duratia) is not FDA-approved for use in the United States. While dapoxetine has been approved for use in many countries around the world, including India, Europe, and parts of Asia, it has not received FDA approval for the treatment of premature ejaculation in the United States. Why Has Dapoxetine Not Been FDA Approved? Clinical Trial Data: Dapoxetine has undergone various clinical trials, but the FDA has not approved it yet due to Duratia 30 mg about the consistency and reliability of the clinical data, particularly regarding its long-term safety and efficacy. Regulatory Process: The approval process for medications in the U.S. is stringent, and sometimes, even after trials, a drug may not meet the FDA's criteria for approval. Where Is Dapoxetine Approved? India: Dapoxetine is approved and widely used as a treatment for premature ejaculation, often marketed under the brand name Duratia. European Union: It is available in some European countries but typically under a different brand name (e.g., Priligy). Asia: Several countries in Asia also have it approved and available for use. Alternatives Approved by the FDA For men in the U.S. dealing with premature ejaculation, the FDA has approved other treatment options, such as: SSRIs like Paroxetine (Paxil), Sertraline (Zoloft), or Fluoxetine (Prozac), which are used off-label to treat PE due to their serotonin-modulating effects. Topical anesthetics (e.g., lidocaine or prilocaine) can be used as a delay spray or gel. Behavioral therapy and other non-pharmacological treatments like cognitive-behavioral therapy (CBT).