Niko
Editor, Senior Moderator
September 09, 2009 10:51 AM
2 South Korean Drug Makers Get Approval For Human Testing Of Generic Tamiflu
<!--By: Ramjit
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SEOUL, Sept 9 (Bernama) -- South Korea's drug safety watchdog said Wednesday it has given two local pharmaceutical companies the green light to conduct a clinical test to prove their generic version of Tamiflu has the same effect as the original antiviral medicine, reports Yonhap news agency.
According to the Korea Food and Drug Administration (KFDA), Chong Kun Dang Pharmaceutical Corp. and SK Chemicals have received approval to conduct the so-called "bio-equivalence test" using their locally-produced Tamiflu on humans.
If they prove that their generic drugs show the same effect as the original Tamiflu, the pharmaceutical companies could ask for the health authorities to sell the antiviral drug, known to be effective in treating Influenza A (H1N1) patients, Yonhap said.
"Generally, it takes 30 days to approve a test application but we shortened the time to around seven days in reviewing a request given the fast spread of type-A influenza," a KFDA official said.
Currently two others are awaiting approval from the KFDA before starting the test on their generic version of Tamiflu, it added.
Though sales of the drugs will be prohibited until the end of 2016, when main material patents held by a Swiss drug maker expire, the government is expediting the approval of such tests so it can produce the drugs on its own in preparation for a pandemic, officials said.
If the disease becomes pandemic and the supply of Tamiflu is insufficient to treat patients, the government could invoke the right to allow for the sale of locally-produced generic drugs, they added.
South Korea has confirmed more than 6,000 cases of type-A flu infection since it was first reported here in early May.
Most of the patients have recovered but five have died in recent weeks and one has been pronounced brain dead in connection with the disease, according to the latest data.
The government is stepping up efforts to stockpile more treatment drugs and vaccines in order to stem spread of the disease and brace for a pandemic. It is planning to vaccinate around 27 percent of its 49 million people by February next year.
-- BERNAMA
http://www.bernama.com/bernama/v5/newsindex.php?id=439074
2 South Korean Drug Makers Get Approval For Human Testing Of Generic Tamiflu
<!--By: Ramjit
-->
SEOUL, Sept 9 (Bernama) -- South Korea's drug safety watchdog said Wednesday it has given two local pharmaceutical companies the green light to conduct a clinical test to prove their generic version of Tamiflu has the same effect as the original antiviral medicine, reports Yonhap news agency.
According to the Korea Food and Drug Administration (KFDA), Chong Kun Dang Pharmaceutical Corp. and SK Chemicals have received approval to conduct the so-called "bio-equivalence test" using their locally-produced Tamiflu on humans.
If they prove that their generic drugs show the same effect as the original Tamiflu, the pharmaceutical companies could ask for the health authorities to sell the antiviral drug, known to be effective in treating Influenza A (H1N1) patients, Yonhap said.
"Generally, it takes 30 days to approve a test application but we shortened the time to around seven days in reviewing a request given the fast spread of type-A influenza," a KFDA official said.
Currently two others are awaiting approval from the KFDA before starting the test on their generic version of Tamiflu, it added.
Though sales of the drugs will be prohibited until the end of 2016, when main material patents held by a Swiss drug maker expire, the government is expediting the approval of such tests so it can produce the drugs on its own in preparation for a pandemic, officials said.
If the disease becomes pandemic and the supply of Tamiflu is insufficient to treat patients, the government could invoke the right to allow for the sale of locally-produced generic drugs, they added.
South Korea has confirmed more than 6,000 cases of type-A flu infection since it was first reported here in early May.
Most of the patients have recovered but five have died in recent weeks and one has been pronounced brain dead in connection with the disease, according to the latest data.
The government is stepping up efforts to stockpile more treatment drugs and vaccines in order to stem spread of the disease and brace for a pandemic. It is planning to vaccinate around 27 percent of its 49 million people by February next year.
-- BERNAMA
http://www.bernama.com/bernama/v5/newsindex.php?id=439074