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Dong Wha Obtains Approval for Zabolante from MFDS

[Date : 2015-03-20]

Dong Wha’s Zabolante, a quinolone antibacterial compound, received regulatory approval from MFDS (Ministry of Food and Drug Safety) on March 20.

The word “Zabolante” was derived from the name of its major ingredient, zabofloxacin, and the musical term “volante,” meaning swift and light, indicating its fast efficacy.

It was approved as a medication for ABE-COPD (acute bacterial exacerbation ofchronic obstructive pulmonary disease). The disease is caused by the respiratory tract and pulmonary parenchyma that are irreversibly damaged by chronic pulmonary inflammation and obstruction in the respiratory tract. As WHO expects that its prevalence and mortality will increase across the world, the treatment of acute exacerbation is now emerging as a major issue.

In the non-clinical evaluation process, Zabolante showed its strong antibiotic activity on respiratory germs (streptococcus pneumonia, haemophilus, moraxella, etc.) and antibiotic-resistant microbes.

Dong Wha proved the efficacy and safety of five-day zabofloxacin treatment in the phase III clinical trial involving 345 patients, which were conducted by 35 institutes. Zabolante was also selected as the “Third NET (New Excellent Technology) in 2014,”as certified by the Ministry of Health & Welfare. This was because its fast effect was established based on the recovery index reported by the patients compared to the existing seven-day therapy.

A Dong Wha official stated, “The domestic market for quinolone antibacterial compounds is worth some 120 billion won and grows by more than 6% every year. Unfortunately, however, it has been dominated by imported products.”“The approval of Zabolante with fast and safe effects will open a new chapter in the treatment of infectious diseases,” he stressed.

Zabolante was also selected as a recipient of the "Pharmaceutical Industry Consulting Support" program led by Korea Health Industry Development Institute (KHIDI) to promote the advancement of South Korean medications into overseas markets such as the U.S. and Europe. In addition, Dong Wha obtained approval for its phase III clinical trial involvingcommunity-acquired pneumonia from the US FDA, and plans to expand the scope of its use to include the treatment of urinary tract infection. Zabolante is scheduled to be released in the South Korean market in the latter half of 2015.


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