cliffordfosterr
Guest
May 28, 2025
4:29 AM
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No, Fildena 50 mg is not approved by the U.S. Food and Drug Administration (FDA). It is a generic version of sildenafil citrate, the active ingredient in Viagra, manufactured by Fortune Healthcare in India.
While Fildena 50 mg itself is FDA-approved for treating erectile dysfunction (ED) and pulmonary arterial hypertension, Fildena has not undergone the FDA's rigorous approval process. This means it is not legally marketed or sold in the United States .
In India, Fildena is approved by the Central Drugs Standard Control Organization (CDSCO), making it legally available there. However, in the U.S., sildenafil is available only through FDA-approved brands like Viagra and authorized generics from companies such as Teva, Mylan, and Aurobindo. These generics have passed the FDA's stringent standards for safety, efficacy, and manufacturing quality.
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