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Massachusetts Fishing Reports > When was Fildena 50 approved?
When was Fildena 50  approved?
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Jul 01, 2025
12:08 AM
Fildena 50 is a generic version of sildenafil citrate, which is commonly used to treat erectile dysfunction (ED). Sildenafil, the active ingredient in Fildena, was originally approved by the FDA in 1998 under the brand name Viagra. However, Fildena 50, being a generic drug manufactured by Fortune Healthcare, was not approved by the FDA because it's produced in India. Generic versions of sildenafil (like Fildena) are widely available in countries outside of the U.S., and they generally get approval from national regulatory authorities in the countries where they are produced, such Fildena 50 Mg the Indian FDA (the Central Drugs Standard Control Organization, or CDSCO). Key Timeline: 1998: Sildenafil was first approved by the U.S. FDA as Viagra for erectile dysfunction. Post-1998: After Viagra's patent expired in 2013, many generic versions of sildenafil entered the market, including Fildena. These generics were approved by various regulatory authorities in different countries, but not by the FDA for the U.S. market. India: Fildena, as a generic sildenafil, is approved for sale in India by the Central Drugs Standard Control Organization (CDSCO), which is the regulatory body for pharmaceuticals in India. Important Considerations: Regulation in the U.S.: In the United States, sildenafil (under the generic name) is available but it’s primarily marketed by Pfizer as Viagra. 


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