Alembic Pharma bags USFDA approval for Febuxostat Tablets

Alembic Pharmaceuticals Limited has received USFDA approval for its Abbreviated New Drug Application (ANDA) Febuxostat Tablets, 40 mg and 80 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda).

Febuxostat Tablet is a xanthine oxidase (XO) inhibitor indicated for the management of chronic hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat Tablet is not recommended for the treatment of asymptomatic hyperuricemia.

Alembic had previously received tentative approval for this ANDA. Alembic now has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA.

According to IQVIA, Febuxostat Tablets have an estimated market size of US$ 578 million for twelve months ending December 2018.

On Monday, the company has received approval from USFDA for its Abbreviated New Drug Application (ANDA) Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg.

On Tuesday, the stock of Alembic Pharma opened gap up at Rs. 515.70 per share from its previous close of Rs. 503.55. In the morning trading session, it surged by 5.8 per cent to Rs. 533 per share.