ID :
79127
Wed, 09/09/2009 - 14:37
Auther :
Shortlink :
https://www.oananews.org//node/79127
The shortlink copeid
2 S. Korean drug makers get approval for human testing of generic Tamiflu
SEOUL, Sept. 9 (Yonhap) -- 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.
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.
"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.
kokobj@yna.co.kr
(END)
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.
"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.
kokobj@yna.co.kr
(END)
