Zydus Lifesciences secures USFDA okay for dyskinesia treatment drug Amantadine extended-release
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg (USRLD: Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg).
Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India.
Dyskinesia refers to abnormal, involuntary movements that can range from slight twitching to severe, uncontrollable movements. It often affects the face, arms, legs, or trunk and can interfere with daily activities.
This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended release capsules, 68.5 mg.
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The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza Capsules). Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts).
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
