Alembic Pharma-Aleor JV gets tentative USFDA nod for anti-fungal, Tavaborole topical answer by admin- Thursday, August 13th, 2020 04:25:37 PM
Alembic Pharmaceuticals has announced that its joint undertaking Aleor Dermaceuticals Ltd (Aleor) has obtained tentative approval from the United States Food & Drug
Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tavaborole Topical Solution, 5%.The tentatively accepted ANDA is therapeutically equivalent to the reference indexed drug product (RLD), Kerydin Topical Solution, five%, of Anacor Pharmaceuticals, Inc. (Anacor). Tavaborole topical answer, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails because of Trichophyton rubrum or Trichophyton mentagrophytes.
Tavaborole Topical Solution, five% has an estimated market length of US$ 82 million for one year finishing June 2020 in step with IQVIA. Alembic is presently in litigation with Anacor in District Court of Delaware and launch of the product will rely on litigation final results.