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Masse Please refer to your New Drug Application NDA dated and received on September 29 2015 and submitted under section 505 b of the Federal Food Drug and Cosmetic Act FDCA for VIEKIRA XR dasabuvir ombitasvir paritaprevir and extended release tablets 200 mg dasabuvir 8. The status of this postmarketing study must be reported annually according to 21 CFR 314. 81 and section 505B a 3 C of the FDCA. Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that...
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How to fill out dasabuvir ombitasvir paritaprevir and
How to fill out dasabuvir ombitasvir paritaprevir and
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What is dasabuvir ombitasvir paritaprevir and?
Dasabuvir ombitasvir paritaprevir is a medication used to treat chronic hepatitis C infection.
Who is required to file dasabuvir ombitasvir paritaprevir and?
Patients prescribed dasabuvir ombitasvir paritaprevir are required to file it.
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Dasabuvir ombitasvir paritaprevir should be filled out as directed by the healthcare provider or pharmacist.
What is the purpose of dasabuvir ombitasvir paritaprevir and?
The purpose of dasabuvir ombitasvir paritaprevir is to cure hepatitis C infection and improve liver function.
What information must be reported on dasabuvir ombitasvir paritaprevir and?
Patients need to report any side effects or changes in their health condition while taking dasabuvir ombitasvir paritaprevir.
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