Federal health regulators have declined to approve a lotion developed by Valeant Pharmaceuticals to treat plaque psoriasis, a common skin condition.
The Food and Drug Administration did not point to anything lacking in the safety or efficacy of the treatment, called Duobrii, Valent said in a statement on Monday. The agency's letter "only noted questions regarding pharmacokinetic data," Joseph Papa, Valeant's chairman and CEO, said.
Valeant shares fell nearly 7 percent in early morning trade after news of the FDA denial came out.
The drugmaker has asked for a meeting with the FDA to settle the matter, which Valeant hopes to resolve quickly, the company said.