Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC (Sanofi-Aventis). Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Teriflunomide Tablets, 7 mg and 14 mg have an estimated market size of US$ 1.6 billion for twelve months ending December 2018 according to IQVIA. Alembic has settled the litigation and will launch the product as per the terms of the settlement.
Alembic now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.538 as compared to the previous close of Rs. 533.65. The total number of shares traded during the day was 910 in over 98 trades.
The stock hit an intraday high of Rs. 540 and intraday low of 530.2. The net turnover during the day was Rs. 486298.