Alembic Pharma gets USFDA nod for Fenofibrate Capsules
Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia(Fredrickson Type IV and V hyperlipidemia).;
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, has recently announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tricor Micronized Capsules, 67 mg, 134 mg and 200 mg, of AbbVie Inc. (AbbVie).
Fenofibrate Capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipideniia (Fredrickson Types Ila and llb).
Lipidaltering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).
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