Canadian drugmaker Valeant Pharmaceuticals International, Inc. (VRX.TO, VRX) Tuesday said the U.S. Food and Drug Administration or FDA has rejected its New Drug Application for efinaconazole for the treatment of onychomycosis, raising questions related to container closure apparatus.
Onychomycosis, also known as dermatophytic onychomycosis, is a fungal infection of fingernails or toenails and constitutes about a half of all nail abnormalities.
According to Valeant, the FDA's complete response letter has not raised any efficacy or safety issues, but the questions pertain only to chemistry, manufacturing and controls related areas of the container closure apparatus.
Valeant believes that the items in the response letter can be addressed and is working for a timely response to the FDA.
A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.
On Monday, Valeant and Bausch + Lomb Holdings Inc., announced a definitive agreement for Valeant to acquire the eyecare company for $8.7 billion in cash. The transaction is expected to be immediately accretive to Valeant's cash earnings per share.
Bausch + Lomb operates in three segments: Pharmaceutical, Vision Care and Surgical. The purchase helps Valeant capitalize on growing eye health trends, against the background of an aging patient population, higher rate of diabetes and demand from emerging markets.
On the Toronto Stock Exchange, VRX.TO is currently trading at C$98.05, up 2.30 percent. On the NYSE, Valeant shares are currently up 10.89 percent and trade at $93.67, on a volume of 3.37 million shares.
For comments and feedback: editorial@rttnews.com