NEW DELHI: Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for anti-fungal Tavaborole Topical Solution.
Tavaborole Topical solution is an antifungal indicated for the treatment of onychomycosis of the toenails.
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tavaborole Topical Solution, 5 per cent, Alembic Pharmaceuticals said in a BSE filing.
Aleor had previously received tentative approval for this ANDA.
“Aleor was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity,” the company added.
Quoting IQVIA data, Alembic Pharma said Tavaborole Topical Solution, 5 per cent, had an estimated market size of USD 82 million for twelve months ending June 2020.
Alembic Pharma has a cumulative total of 133 ANDA approvals (116 final approvals and 17 tentative approvals) from the USFDA.
Source: Press Trust of India
