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Nov 25, 2024
1:36 AM
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Fildena 100 mg is a brand of Sildenafil Citrate, a medication commonly used to treat erectile dysfunction (ED). It works by increasing blood flow to the penis, helping men achieve and maintain an erection during sexual activity.
Fildena, like other sildenafil-based medications, is typically approved for medical use by national regulatory authorities that oversee the safety, efficacy, and quality of pharmaceuticals. Here’s an overview of the agencies involved in the approval process:
1. U.S. Food and Drug Administration (FDA)
FDA Approval: In the United States, Sildenafil Citrate (the active ingredient in Fildena 100 mg) was first approved by the FDA in 1998 under the brand name Viagra. This approval was granted after clinical trials demonstrated its efficacy in treating erectile dysfunction.
Generic Versions: Once the patent for Viagra expired, generic versions like Fildena became available. While the FDA does not specifically approve brand names like Fildena, Sildenafil Citrate in generic forms must meet the same standards of safety, efficacy, and quality as the original brand (Viagra).
Approval Process: Generic medications, including Fildena, are usually approved through an Abbreviated New Drug Application (ANDA), which ensures that they are equivalent to the original branded medication.
2. European Medicines Agency (EMA)
EMA Approval: In Europe, Sildenafil (under various brand names) was first approved for the treatment of erectile dysfunction in the late 1990s. The EMA reviews and approves medications for use in the European Union (EU) member states.
Generic Availability: Fildena 100 mg and other generic forms of Sildenafil are available in many European countries after meeting EMA’s standards for generic drug approval.
3. National Regulatory Agencies
In other countries, the approval of Sildenafil Citrate and its generic forms, like FILDENA 100 MG is handled by national regulatory authorities. These include:
Health Canada in Canada
Therapeutic Goods Administration (TGA) in Australia
Central Drugs Standard Control Organization (CDSCO) in India
Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom
Each of these agencies ensures that generic versions like Fildena meet the necessary standards for safety, quality, and efficacy before they can be marketed and sold.
4. WHO (World Health Organization)
The World Health Organization (WHO) doesn’t approve drugs for individual countries but recognizes essential medicines that should be available globally. Sildenafil is included in the WHO’s List of Essential Medicines, which further emphasizes its importance in treating erectile dysfunction and related health conditions.
Summary
While Fildena 100 mg itself may not be directly approved by regulatory bodies like the FDA, Sildenafil Citrate (its active ingredient) has undergone rigorous clinical trials and regulatory reviews. Generic versions of sildenafil, including Fildena, are approved by national health authorities in various countries, ensuring they meet the same standards for safety and effectiveness as the original branded medications like Viagra.
If you're considering using Fildena 100 mg, it's important to purchase it from reputable sources, ensuring it has been approved and regulated by the relevant authorities in your country.
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