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Udenafil, a relatively new erectile dysfunction drug developed by South Korea’s Mezzion Pharma, has thus far failed to win approval in key markets such as the European Union and the United States.
Don’t expect to see udenafil, a new oral ED drug developed in South Korea, available for sale in the United States within the near future.
The U.S. Food and Drug Administration rejected Mezzion Pharma’s new drug application for the medication back in 2017 after finding that the drug was being produced in facilities that failed to meet FDA standards.
The FDA’s rejection triggered the South Korean biotech company to file suit against Dr. Reddy’s Laboratories, which had been contracted by Mezzion to manufacture the drug. In its filing, Mezzion claimed that Indian-based Dr. Reddy’s hid “significant deficiencies” and misrepresented its compliance with the FDA’s standards for current good manufacturing practice.
An Alternative to Cialis?
Had udenafil won FDA approval, it would have provided an alternative to Cialis (tadalafil). At higher dosage, udenafil has a half-life similar to that of high-strength Cialis. At lower dosage, udenafil might well provide competition for Cialis’s daily medication, currently the only ED drug of its type available in the United States.
Sold under the brand-name Zydena in some markets, udenafil is currently available only in South Korea, the Philippines, and Russia. It also has thus far failed to win approval of the European Medicines Agency, which is responsible for regulating the prescription drug market in the European Union.
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