Alembic Pharma now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals shares gained more than a percent intraday on April 22 after the US health regulator approved Teriflunomide tablets, which are available in 7 mg and 14 mg strength.
The stock was quoting at Rs 541.20, up Rs 6.80, or 1.27 percent on the BSE, at 11:20 hours IST.
The approved abbreviated new drug application (ANDA) Teriflunomide is therapeutically equivalent to the reference listed drug (RLD), Aubagio tablets of Sanofi-Aventis US, LLC, Alembic said.
Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Teriflunomide has an estimated market size of $1.6 billion for twelve months ending December 2018, according to IQVIA data.
Alembic said it had settled the litigation and would launch the product as per the terms of the settlement.The pharma company now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.