Alembic Pharmaceuticals receives USFDA approval for Entacapone Tablets

11 Jan 2022 , 01:34 AM

Alembic Pharmaceuticals Alembic today announced that it has received final approval from the US Food Drug Administration USFDA 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 Parkinsons disease Entacapone Tablets USP 200 mg have an estimated market size of US$ 105 million for twelve months ending September 2021 according to IQVIA