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KUVAN (nda022181)- (100MG)

SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM
100MG
Yes No
2026-May-16 2012-Dec-13
2014-Dec-13 None
None No
Kuvan is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
3 0 3
Total Other Developers 6
Drugs with Suitability No
100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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