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    10 More Newly Approved Drugs

    The FDA is having a productive 2017.

     

    Brineura bottles

    BRINEURA (cerliponase alfa), BioMarin

    Indications: A hydrolytic lysosomal N-terminal tripeptidyl peptidase indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

    Dosage: Injection: Brineura 150 mg/5 mL (30 mg/mL) solution, two single-dose vials per carton co-packaged with Intraventricular Electrolytes Injection 5 mL in a single-dose vial. Brineura is administered to the cerebrospinal fluid by infusion via a surgically implanted reservoir and catheter.

    Contraindications: Acute complications related to the intraventricular access device(e.g., leakage, device failure, or device-related infection) or patients with ventriculoperitoneal shunts.

    Read the prescribing information here

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