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M2 EQUITYBITES-June 19, 2017-Lannett wins US FDA approval for Amantadine Hydrochloride Capsules USP, 100 mg
The company said the ADS-5102 (amantadine hydrochloride) application has been given a US FDA Prescription Drug User Fee Act (PDUFA) target action date of 24 August 2017.
Clinical trials have documented that amantadine hydrochloride [4,5,7,8,13] and its analog rimantadine hydrochloride [3,5,10,13,15] are effective drugs for the prophylaxis and treatment of influenza A virus infection.
HONOLULU - Amantadine hydrochloride effectively improved functional recovery in patients in a vegetative or minimally conscious state after traumatic brain injury, results from a 6-week, randomized, multicenter study showed.
The treatment regimen that has been used with apparent anecdotal success is a combination of celecoxib (20 mg/kg PO, q24h; Celebrex; Pfizer Corp, New York, NY, USA) and an antiviral medication, amantadine hydrochloride (10 mg/kg PO, q24h; Symmetrel; Banner Pharmacaps Inc, High Point, NC, USA).
Effect of amantadine hydrochloride on symptoms of frontal lobe dysfunction in brain injury: Case studies and review.
Rimantadine hydrochloride and amantadine hydrochloride use in influenza A virus infections.
Two treatment choices were included in the analysis: amantadine hydrochloride and oseltamivir phosphate (the only drugs currently licensed for the treatment of influenza in children younger than 7 years), and two rapid diagnostic tests were considered: QuickVue (Quidel Corp., San Diego) and ZstatFlu (ZymeTx Inc., Oklahoma City).