NE BUSINESS BUREAU
NEW DELHI, AUG 13
Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received tentative approval from the US health regulator for Tavaborole Topical Solution, 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 percent, of Anacor Pharmaceuticals, Inc.
“Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its ANDA Tavaborole Topical Solution, 5 percent,” Alembic Pharmaceuticals said in a regulatory filing.
Alembic Pharma said it is currently in litigation with Anacor in the District Court of Delaware and the launch of the product will depend on litigation outcome.
Quoting IQVIA data, Alembic Pharma said Tavaborole Topical Solution, 5 percent, 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.
Aleor Dermaceuticals is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies focusing on commercialising dermatology products globally.
Shares of Alembic Pharmaceuticals were trading 1.45 percent higher at Rs 1,091.85 apiece on the BSE.
