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    9 Newly Approved Novel Drugs

    It's been a busy year for the FDA.


    Old Woman clutching cane

    7. Xadago (safinamide), Newron Pharmaceuticals

    Indications: A monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

    Dosage: Initial dosage is 50 mg PO daily. After 2 weeks, may increase dose to 100 mg PO daily , based on individual need and tolerability.

    Contraindications: Severe hepatic impairment or hypersensitivity to the active substance or to any of the excipients. Coadministration with other MAOIs; opioids; St John’s wort, or tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate or amphetamine and their derivatives; Dextromethorphan; or selective norepinephrine reuptake inhibitors.

    Read the FDA statement here

    Read the full prescribing information here

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