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Last Updated : Dec 05, 2018 11:58 AM IST | Source: PTI

Alembic Pharma gets USFDA nod for hypertension drug

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Candesartan Cilexetil tablets USP in the strengths of 4 mg, 8 mg, and 16 mg, Alembic Pharmaceuticals said in a filing to BSE.

 
 
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Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Candesartan Cilexetil tablets, used for treatment of hypertension.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Candesartan Cilexetil tablets USP in the strengths of 4 mg, 8 mg, and 16 mg, Alembic Pharmaceuticals said in a filing to BSE.

The approved product is therapeutically equivalent to the reference listed drug product (RLD), Atacand tablets of ANI Pharmaceuticals.

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Quoting to IQVIA data, Alembic Pharma said Candesartan Cilexetil tablets have an estimated market size of USD 22 million for twelve months ending December 2017.

The company currently has a total of 82 ANDA approvals from USFDA, it added.

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First Published on Dec 5, 2018 11:55 am
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