Alembic Pharma bags USFDA nod for high BP traetment drug
Vadodara: Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for Amlodipine and Atorvastatin Tablets, used to treat high blood pressure.
The approval is for its Abbreviated New Drug Application (ANDA) of Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of Pharmacia and Upjohn Co. LLC.
Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
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Alembic has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA.
Last year, Medical Dialogues team had reported that Alembic Pharma had received final approval from the USFDA for its ANDA for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
Read also: Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ER
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
