New Delhi: Drug firm Alembic Pharmaceuticals on Monday said it has received approvals from the US health regulator for its Teriflunomide tablets and Tobramycin ophthalmic solution.
The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.
The product is generic version of Sanofi-Aventis US LLC’s Aubagio tablets in the same strengths, it added. According to IQVIA, teriflunomide tablets, 7 mg and 14 mg have an estimated market size of USD 1.6 billion for 12 months ending December 2018, Alembic Pharma said.
Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis, Alembic Pharma said.
The company has also received approval from the USFDA for its ANDA for Tobramycin ophthalmic solution USP, 0.3 per cent, it added.
The product is generic version of Novartis Pharmaceuticals Corporation’s Tobrex ophthalmic solution in the same strength, Alembic Pharma said.
Citing IQVIA, the company said tobramycin ophthalmic solution USP, 0.3 per cent have an estimated market size of USD 9.6 million for twelve months ending December 2018.
The product is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria, Alembic Pharma said.
The company now has a total of 92 ANDA approvals (80 final approvals and 12 tentative approvals) from USFDA, it added.