May 28 Canada drugmaker Valeant Pharmaceuticals
International said on Tuesday that the U.S. Food and
Drug Administration denied approval for its drug to treat
onychomycosis, a fungal infection of the nail.
The U.S. health regulator raised questions about
manufacturing and controls related to the drug's container in a
complete response letter to the company.
Valeant said the FDA did not raise any questions regarding
the efficacy or safety of the drug efinaconazole.
The company said it was working on a timely response to the
Onychomycosis causes nails to deform, discolor, thicken,
become brittle and split and separate from the nail bed.
Quebec-based Valeant said on Monday it would buy Bausch &
Lomb Holdings Inc from Warburg Pincus LLC for $8.7 billion, a
deal set to vault the Canadian company into the upper ranks of
the global pharmaceutical sector.