| Document Date: 2014-04-16 09:20:43
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Company BioMarin Pharmaceutical Inc. / Ames / / Event Product Issues / / IndustryTerm active pharmaceutical ingredient / chemical name / food intake / food / observed following food intake / / MedicalCondition polyuria / microcephaly / benign adrenal pheochromocytoma / abdominal pain / convulsions / mild dizziness / flushing / respiratory failure / headache / arthralgia / seizures / dyspnea / Hypersensitivity Reactions Including Anaphylaxis / severe mental retardation / Carcinogenesis / nausea / responsive Phenylketonuria / anaphylaxis / coughing / nasal congestion / cardiovascular disease / upper abdominal pain / patient reported mild headache / holoprosencephaly / pain / vomiting / myocardial infarction / neurologic disorders / Gastritis / PKU / Hypersensitivity / diarrhea / dizziness / cough / rash / pharyngitis / wheezing / disorders / upper respiratory tract infection / hypotension / / Organization US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / / Product potassium citrate / Kuvan Tablets Kuvan / KUVAN / DOSAGE FORMS AND STRENGTHS Kuvan / mannitol / Phe metabolism / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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