Alembic Pharma gets US FDA nod for three generic drugs

Alembic Pharmaceuticals said it has received US FDA nod to sell three generic drugs and formulations in the US with a combined annual market size of over $600 million in the country.

All three are based on the core ingredient Deferasirox, which is used to treat chronic drug overload due to blood transfusions in patients who are at least two years of age.

Alembic’s Deferasirox tablets of 90mg and 360mg have been given final approval, while the 180mg tablet has been given only tentative approval, which means that the company can launch the product in the market only after the final patent or protection runs out.

Deferasirox is sold in the branded market as Jadenu by Novartis Pharmaceuticals Corp.

In addition to the tablets, Alembic also got the nod to sell Deferasirox tablets for oral suspension in three doses 125 mg, 250 mg and 500 mg.

With these three generic drugs, Alembic now has a total of 107 approvals for generic drugs in the US market, out of which 95 are final and 12 are tentative.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company established in 1907 and manufactures and markets generic pharmaceutical products all over the world.