Alembic gets FDA nod for 2 generics
Alembic Pharmaceuticals has received the Food and Drug Administration’s clearance for two generics — a generic of Abbvie’s Tricor (fenofibrate tablets) and Novartis’ Vigamox (moxifloxacin ophthalmic solution, 0.5%).
The FDA’s approval for generic Tricor was granted to Alembic’s subsidiary Orit Labs. The generic will be available in 54- and 160-mg dosage strengths. Ajanta’s generic Tricor is indicated as an adjunct to diet to reduce elevated LDL cholesterol, total cholesterol, triglycerides 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.
Fenofibrate tablets had a market value of $92 million for the twelve months ending December 2018, according to IQVIA.
Alembic’s generic Vigamox is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms.
The product had a market value of $68 million, for the twelve months ending December 2018, according to IQVIA.
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