Alembic gets FDA nod for two generics

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Alembic gets FDA nod for two generics

By Sandra Levy - 08/13/2019
Alembic has received the Food and Drug Administration’s clearance for its generic Tricor (fenofibrate) tablets. The generic of AbbVie's branded product will be available in dosage strengths of 48 mg and 145 mg.

The drug is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolernla or mixed dyslipidemia. It also is indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.

Fenofibrate tablets 48 mg and 145 mg had a market value of about $94 million for the year ended December 2018, according to IQVIA.

Alembic also received the FDA’s nod for dorzolamide hydrochloride ophthalmic solution, 2%, a generic of Merck Sharp & Dohme's Trusopt ophthalmic solution.

The product is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dorzolamide hydrochloride ophthalmic solution, 2% had a market value of roughly $35 million for the 12 months ended December 2018, according to IQVIA.

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