Drug firm Alembic Pharma on Wednesday said it has received approval from the US health regulator for Fenofibrate capsules, which reduces cholesterol and triglycerides in blood.
The approved product is therapeutically equivalent to the reference listed drug product Tricor Micronized Capsules of AbbVie Inc.
In a regulatory filing, Alembic Pharma said it has “received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Fenofibrate capsules USP in the strengths of 67 mg, 134 mg and 200 mg.”
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.
Quoting IQVIA, Alembic Pharma said Fenofibrate capsules USP, 67 mg, 134 mg and 200 mg have an estimated market size of $17 million for 12 months ending June 2020.
Alembic Pharma has a cumulative total of 133 ANDA approvals (115 final approvals and 18 tentative approvals) from USFDA.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.