The regulatory body that oversees the approval of Avana 50 mg (which contains Avanafil, a medication used for erectile dysfunction) depends on the country in which it is being sold. The primary regulatory authorities include:
U.S. Food and Drug Administration (FDA): In the United States, the FDA is responsible for approving and regulating pharmaceutical drugs, including Avanafil.
European Medicines Agency (EMA): In the European Union, the EMA oversees the approval of medications for use within member states.
Drug Controller General of India (DCGI): In India, the DCGI is responsible for the regulation and approval of pharmaceutical products.
Other national regulatory agencies: Depending on the country, other regulatory bodies such as Health Canada, the Therapeutic Goods Administration (TGA) in Australia, or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK may be responsible.
If you're specifically looking for information on Avana 50 mg approval in a certain region, let me know, and I can provide more detailed information.