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ORKAMBI (nda206038)- (125MG;200MG,125MG;100MG)

IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC
125MG;200MG,125MG;100MG
No No
2030-Dec-11 2020-Jul-02
2022-Jul-02 None
2028-Jan-02 No
ORKAMBI is a combination of lumacaftor and ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.
0 0 0
Total Other Developers 2
Drugs with Suitability No
125MG;200MG ** ** - - -
125MG;100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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