Alembic Pharma Gets USFDA Nod

New Delhi, Drug firm Alembic Pharmaceuticals on Friday said it has received approvals from the US health regulator for its generic Deferasirox tablets used for treatment of chronic iron overload due to blood transfusions in patients over two years of age.

The company has received final approvals from the United States Food and Drug Administration (USFDA) for its Deferasirox tablets in the strengths of 90 mg and 360 mg and Deferasirox tablets for oral suspension in the strengths of 125 mg, 250 mg, and 500 mg, Alembic Pharmaceuticals said in a regulatory filing.

The tablets are generic versions of Novartis Pharmaceuticals Corporation’s Jadenu tablets and Exjade tablets for oral suspension in the same strengths, it added.

The company has also received tentative nod from the US health regulator for its Deferasirox tablets in the strength of 180 mg, Alembic Pharmaceuticals said.

According to IQVIA, estimated market size for Deferasirox tablets in the strengths of 90 mg and 360 mg was USD 415 million for the 12 months ending December 2018, it added.

The estimated market size for Deferasirox tablets for oral suspension in the three strengths was USD 135 million for the 12 months ending December 2018 as per IQVIA, Alembic Pharmaceuticals said.

Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older. It is also used for treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes.

The company now has a total of 107 abbreviated new drug application (ANDA) approvals (95 final approvals and 12 tentative approvals) from the US health regulator, it added.-Times Of India