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    Alembic Pharma gets final USFDA nod for Fenofibrate tablets

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-01-23T14:56:12+05:30  |  Updated On 23 Jan 2020 2:56 PM IST
    Alembic Pharma gets final USFDA nod for Fenofibrate tablets

    New Delhi: Alembic Pharmaceuticals on Thursday said it has received final nod from the US health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in the blood. "Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg.

    "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc (AbbVie)," the drug firm said in a BSE filing.

    Fenofibrate tablets have an estimated market size of USD 100 million for twelve months ending September 2019, according to IQVIA.

    Read also: Alembic Pharma gets USFDA nod for spasticity drug Tizanidine

    "Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia," it said.

    Alembic has a cumulative total of 113 ANDA approvals -- 100 final approvals and 13 tentative approvals -- from the USFDA.

    Read also: Alembic Pharma gets two USFDA observations for Karkhadi facility

    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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