Delayed Release of New Anti-Impotence Drug in South Korea

The release of a new anti-impotence drug, Zydena, by South Korea's largest drug company, Dong-A Pharmaceutical, is likely to be delayed due to concerns over cancer-causing substances. The Korea Food and Drug Administration (KFDA) has ordered the company to provide additional information on its submitted files for screening. The regulator rejected Dong-A's request for an exemption from filing detailed reports, citing concerns over equity among overseas competitors.

Key Takeaways:

• The Korea Food and Drug Administration (KFDA) has ordered Dong-A Pharmaceutical to provide more details on its submitted files for the screening of Zydena, a new anti-impotence drug.
• The KFDA rejected Dong-A's request for an exemption from filing detailed reports, citing concerns over equity among overseas competitors.
• The release of Zydena is likely to be delayed, originally planned for August 15.
• Zydena is reported to be more effective and safer than its predecessors, with a development history dating back to 1999 as part of the South Korean government's research and development program for new drugs.
• The drug is expected to save 3 billion won (US$2.91 million) worth of costs to import similar drugs from overseas.
• Dong-A Pharmaceutical is the largest drug company in South Korea, and Zydena is the world's fourth anti-impotence drug after Viagra, Cialis, and Levitra.

Statistics:

• 3 billion won (US$2.91 million) worth of costs saved by importing similar drugs from overseas with the release of Zydena.
• August 15: original release date for Zydena, now likely delayed due to concerns over cancer-causing substances.
• 1999: the year in which the development of Zydena started as part of the South Korean government's research and development program for new drugs.

Sources:

• Yonhap
• Asia Pulse
• Korea Food and Drug Administration (KFDA)