Pharmacogenomic Information

DrugTherapeutic Area*BiomarkerReferenced
Labeling Sections
CFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation carriers, F508del mutation homozygotes

Indications and Usage
Adverse Reactions
Use in Specific Populations
Clinical Pharmacology
Clinical Studies

* Therapeutic areas do not necessarily reflect the CDER review division.
† Standard nomenclature is used for genes as per the Human Genome Organization symbol, cytogenetic abnormalities as per the International System for Human Cytogenetic Nomenclature, or other conventions.


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Page Last Updated: 04/14/2015
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