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Author Topic: Question: Sofosbuvir has a target review date for Dec. 8, 2013...  (Read 10057 times)

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Offline d-boy86

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Sofosbuvir has a target review date for Dec. 8, 2013. Does this mean that's when they expect an approval? Also, after it is approved--how long does it take for the medications to be available for the public?

Offline iana5252

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Re: Question: Sofosbuvir has a target review date for Dec. 8, 2013...
« Reply #1 on: June 25, 2013, 01:08:30 pm »
Quote
Sofosbuvir has a target review date for Dec. 8, 2013. Does this mean that's when they expect an approval?

Yes, that is the date by which the FDA is expected to make a decision on the drug.

Quote
Also, after it is approved--how long does it take for the medications to be available for the public?

Both Victrelis (boceprevir) and Incivek (telaprevir) were available within weeks of approval. We expect a similar timeline with sofosbuvir.

Offline d-boy86

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Re: Question: Sofosbuvir has a target review date for Dec. 8, 2013...
« Reply #2 on: July 12, 2013, 11:19:40 am »
Yes, that is the date by which the FDA is expected to make a decision on the drug.

Both Victrelis (boceprevir) and Incivek (telaprevir) were available within weeks of approval. We expect a similar timeline with sofosbuvir.
Thanks! So it safe to assume that the drug will be available for use within the 1st half of 2014?

 


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