9 Newly Approved Novel Drugs
It's been a busy year for the FDA.
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.