The specialty pharmaceutical company, Valeant Pharmaceuticals International, Inc., through its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, has received FDA approval for its new drug application for Jublia (efinaconazole 10% topical solution), the a topical triazole approved for the treatment of onychomycosis of the toenails.

Valeant acquired Jublia through its purchase of Dow Pharmaceutical Sciences, a privately held dermatology company that specializes in the development of topical products, in 2008. It expects to launch the product in the third quarter of 2014 and expects peak US sales of $300 million to $800 million, according to a company statement. It is currently working on other approvals outside the US.

Jublia is the fourth product from Valeant’s acquisition of Dow Pharmaceutical Sciences, which received FDA approval. The others are: 1% clindamycin and 5% benzoyl peroxide gel (IDP 111) (which was later divested), Acanya (benzoyl peroxide and clindamycin), and Retin-A Micro (tretinoin) gel microsphere 0.08%. The company has also filed with FDA for approval of a new treatment for acne, Onexton, which has a PDUFA date of November 30, 2014.

The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has also agreed to supply Valeant with the finished dosage form of Jublia for the US market.

Source: Valeant Pharmaceuticals