Is Fildena Chewable 100 mg FDA-approved?

Fildena Chewable 100 mg is not clearly FDA-approved, even though its active ingredient is the FDA-approved drug Sildenafil Citrate (the same substance in Viagra). Here’s how Why chewable Fildena is different / likely not FDA-approved The FDA has warned consumers about unapproved “ED” pills sold online — especially chewable or “power-pill” versions — that claim to be like Viagra. U.S. Food and Drug Administration According to a recent overview, while sildenafil (the active ingredient) is FDA-approved, “chewable” or compounded versions generally have not been separately approved. WebMD +1 Regulatory approval requires more than the active ingredient — it requires that particular formulation (film-coated tablet, chewable, dissolving, etc.) to pass quality, safety, and manufacturing standards. There is no public FDA labeling or approval for a chewable sildenafil tablet by brand Fildena Chewable 100mg Risks & concerns with unapproved ED pills Products sold as “chewable sildenafil” (or similar) may come from outside the U.S. (often India) and may not meet FDA manufacturing or quality standards. U.S. Food and Drug Administration +1 Their actual contents may vary; some have been found to be counterfeit, contaminated, or mislabeled. U.S. Food and Drug Administration As a result, safety — including correct dosage, purity, and side-effect profile — cannot be guaranteed. What this means in practical terms Even though the active drug (sildenafil) is approved, using “Fildena Chewable 100 mg” in the U.S. carries uncertainty: the formulation itself is likely unapproved. Using such unapproved ED pills might expose you to greater risk of side effects, unexpected potency, or adulteration. If you need sildenafil, it's safer (and recommended) to request from a licensed physician a legitimate, FDA-approved sildenafil tablet (e.g. generic sildenafil or Viagra), rather than unverified chewables from internet sellers.

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