Alembic gets USFDA approval for generic heart drug

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets.

Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US for the three dosages for which approval has been received — 4 mg, 8 mg, and 16 mg.

The generic version, Candesartan cilexetil, is therapeutically equivalent to Atacand.

Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to up to 17 years of age by lowering blood pressure.

It is also used for the treatment of heart failure.

With this, Alembic has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.

Alembic, founded in 1907, manufactures and markets generic pharmaceutical products all over the world.

It is also one of the leaders in branded generics in lndia, and has a marketing team of over 5,000 in its home market.