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Hepatitis C Main Forums => On Hepatitis C Treatment => Topic started by: d-boy86 on June 24, 2013, 04:46:35 pm

Title: Question: Sofosbuvir has a target review date for Dec. 8, 2013...
Post by: d-boy86 on June 24, 2013, 04:46:35 pm

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?

Title: Re: Question: Sofosbuvir has a target review date for Dec. 8, 2013...
Post by: iana5252 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.

Title: Re: Question: Sofosbuvir has a target review date for Dec. 8, 2013...
Post by: d-boy86 on July 12, 2013, 11:19:40 am

Quote from: iana5252 on June 25, 2013, 01:08:30 pm

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?