Categories: US FDA Approval

Alembic Pharma gets USFDA nod for Candesartan Cilexetil tablets

Mumbai, June 22, 2017: Alembic Pharmaceuticals has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Candesartan Cilexetil Tablets, 32 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Atacand Tablets, 32 mg of AstraZeneca Pharmaceuticals LP. Candesartan Cilexetil Tablets are indicated for treatment of hypertension in adults and children and treatment of heart failure (NYHA class II-IV).

Candesartan Cilexetil Tablets, 32mg have an estimated market size of USD 27 million for twelve months ending December 2016, according to IMS.

United News of India

The Pharma Times News Bureau

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