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Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for entacapone tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan tablets, 200 mg, of Orion Corporation.
Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease.
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021 according to IQVIA. Alembic has received year to date (YTD) 17 approvals (13 final approvals and 4 tentative approvals) and a cumulative total of 156 ANDA approvals (136 final approvals and 20 tentative approvals) from US FDA.
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