Drug firm Alembic Pharmaceuticals’s joint venture firm Aleor Dermaceuticals has received tentative approval from the US health regulator for Tavaborole Topical Solution.
The solution is used to treat fungal toenail infections. The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Kerydin Topical Solution, 5 per cent, of Anacor Pharmaceuticals, Inc.
Aleor Dermaceuticals is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies focusing on commercialising dermatology products globally.
“Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its ANDA Tavaborole Topical Solution, 5 per cent,” Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharma is currently in litigation with with Anacor in District Court of Delaware and launch of the product will depend on litigation outcome.
Tavaborole Topical Solution, 5 per cent, has an estimated market size of USD 82 million for 12 months ending June 2020. Alembic now has a total of 128 ANDA approvals (112 final approvals and 16 tentative approvals) from USFDA.