Alembic Pharma gets USFDA nod for Clonazepam orally disintegrating tablets
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Clonazepam orally disintegrating tablets, in the strengths of 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg, Alembic Pharmaceuticals said in a filing to BSE.
New Delhi: Drug firm Alembic Pharmaceuticals Monday said it has received approval from the US health regulator for Clonazepam orally disintegrating tablets, used for the treatment of seizures.
The approved product is therapeutically equivalent to the reference listed drug Klonopin orally disintegrating tablets of Hoffmann-La Roche, Inc.
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Quoting IQVIA data, Alembic Pharma said Clonazepam orally disintegrating tablets USP has an estimated market size of USD 20 million for 12 months ending December 2018.
Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures.
The company currently has a total of 98 ANDA approvals (86 final approvals and 12 tentative approvals) from USFDA, it added.
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Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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