 "Alembic Pharma gets USFDA nod for generic drug to treat Parkinson's disease")
Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic Entacapone tablets indicated for patients with Parkinson's disease.
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Entacapone tablets is for strength of 200 mg, the company said in a regulatory filing.
It 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 other medications, levodopa and carbidopa, to treat end-of-dose "wearing-off" in patients with Parkinson's disease.
Citing IQVIA data, Alembic said Entacapone tablets 200 mg have an estimated market size of USD 10.5 million for 12 months ended September 2021.
In the ongoing fiscal so far, the company said it has received 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 USFDA.