Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg, of Orion Corporation.

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Refer label for a detailed indication.

Alembic has a cumulative total of 234 ANDA approvals (214 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 799.05 as compared to the previous close of Rs. 809.75. The total number of shares traded during the day was 5027 in over 404 trades.

The stock hit an intraday high of Rs. 809.75 and intraday low of 777.80. The net turnover during the day was Rs. 3976303.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA Carbidopa Levodopa Entacapone Tablets