Korean Antibiotic Gets FDA Approval

Factive, Quinolone antibiotic developed by LG Life Sciences Ltd., was officially approved by the US Food and Drug Administration (FDA). For the first time a new drug developed by a Korean company was approved by the US FDA.

LG Life Sciences said on the 6th that Factive developed with its own technology was approved by the US FDA on the 5th as a cure for treating a common type of pneumonia and flare-ups of chronic bacterial bronchitis.

This is the first time a novel drug developed by a Korean pharmaceutical company was approved by the US FDA, With this feat, Korea has joined the ranks of ten countries that registered new drugs to the US FDA along with the US, Japan and Britain.

With its quick and strong antibiosis effect, few side effects and the convenience of taking the medicine, company researchers said that Factive was a broad-spectrum antibacterial agent and treated respiratory pathogens and pneumococci better than existing ones.

Especially, Factive can kill resistant bacteria generated by Penicillin. It is reported that Penicillin generated resistant bacteria in about 70 to 80% of domestic users.

Earlier, Factive had been approved by New Zealand in 2001 and by the Korea FDA IN 2002. LG Life Sciences decided to apply for an approval in Britain, Canada and Hungary.

The company expects to rake in up to 80 billion won on an annual basis when Gene Soft, a US company strategically partnered with LG Life Sciences, sells the raw materials and products in earnest in Asia, Latin America and Africa.

LG Life Science plans to bring Factive to a domestic market in late July when the company decides the drug`s price.

Jin Lee leej@donga.com