FDA Approved Medical Products for:

Phenylketonuria

The table(s) below may not be an exhaustive list of drugs or products used to treat this condition. There may be other products available that are not considered orphan products.

Generic Name Sapropterin
Trade Name
(Manufacturer Name)
Kuvan®
(Biomarin Pharmaceutical Inc.)
Indication
The FDA has approved this product to be used in this manner.
Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
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