Alembic Pharmaceuticals gets USFDA nod for Fenofibrate Capsules

Alembic Pharmaceuticals 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.

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 dyslipidemia (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).

Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg have an estimated market size of $17 million for twelve months ending June 2020 according to IQVIA.

Alembic has a cumulative total of 133 ANDA approvals (115 final approvals and 18 tentative approvals) from USFDA.