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SOFOSBUVIR

What a Status of Tab Sofosbuvir about approval of FDA?
i need urgent this tablets.
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Avatar universal
You are posting on an old thead.  That was 2 years ago.

Now several companies are producing or are getting ready to produce sofosbuvir in India.  Should be available this month or next from what I understand.

Also, the next generation, a single pill 'cocktail', sofosbuvir and ledisprevir, will be in production by the end of the year.

There are a couple of good threads on here discussing this issue.  Please read through them for more specific information.
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Avatar universal
how sad.. and what a shame.. !!! neither India can manufacture medicine like sofosbuvir nor it allows a reputed company like Gilead to get a patent and make the medicine available to the  Indians at low price.. Govt has left the Indians to die a slow death...
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446474 tn?1446347682
Sofosbuvir will NOT be available in India next year as far as I know. India has had many issues treating hepatitis C using older treatments and doesn't I believe even had triple therapy that has been available for 2 years in the US and Europe.

If approved by the drug regulatory agencies in the US and Europe it will only be available in the US and Europe and I guess Canada in 2014. India and other countries may have to wait many years for the treatment to be available.

Why do you think you need Sofosbuvir?
The only treats that will be available next year are for genotype 2/3 (Sofosbuvie + Ribavirin) and treatment naive genotypes 1, 4, 5, 6 combined with peg-interferon and Ribavirin.
Have you tried current treatment (peg-interferon and Ribavirin) and failed to cure the virus?

Good luck to you!
Hector
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Avatar universal
Gilead applied for approval of sofosbuvir in April and requested that the decision be fast tracked, so the FDA should make it's decision in October (as Bo said this is for approval in the US).
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Avatar universal
  I did read that Sofosbuvir was turned into the FDA to be reviewed, but I dont know when it will be ready, but hopefully by the end of 2013, and that is for the U.S.
    There are also Clinical Trials that use people for research purposes, and they are going on right now. There are also other new meds being researched, by Abbott
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