FDA Extends Market Exclusivity Six Months For BioMarin Pharmaceutical Inc.'s Rare Disease Therapy KUVAN® (Sapropterin Dihydrochloride) Powder For Oral Solution And Tablets

Published: Apr 14, 2014

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SAN RAFAEL, Calif., April 14, 2014 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN), a global leader in the development and commercialization of therapies for rare genetic diseases, today announced that the Food and Drug Administration (FDA) granted KUVAN® (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension. The FDA action extends KUVAN's market exclusivity to June 2015 and is based on studies submitted in response to a written request by the FDA to investigate the use of KUVAN in pediatric patients from birth to age 6. KUVAN formulated as Tablets and Powder for Oral Solution, is the first and only FDA-approved medication for PKU 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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