Dec 5: Drug maker Alembic Pharmaceuticals Ltd on Wednesday announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg.
According to the company, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Irie. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure.
Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, have an estimated market size of $ 22 million for the twelve months ending December 2017 according to IQVIA.
Alembic has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.