Alembic obtains FDA nod for 2 generics

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Alembic obtains FDA nod for 2 generics

By Sandra Levy - 10/27/2020

Alembic has received the Food and Drug Administration’s green light for two generics.

Alembic’s joint venture Aleor Dermaceuticals has obtained the FDA’s blessing for tavaborole topical solution, in a dosage strength of 5%.

The product is the generic of Anacor’s tavaborole.

It is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Tavaborole topical solution has a market value of roughly $82 million for the 12 months ending June 2020, according to IQVIA.

Alembic also has received the FDA 's clearance for fenofibrate capsules in dosage strengths of 67 mg, 134 mg and 200 mg.

The product is the generic of AbbVie’s Tricor micronized capsules.

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); and as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).

Fenofibrate capsules have a market value of $17 million for the 12 months ending June 2020, according to IQVIA.

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