The FDA delivered a significant blow to Valeant this week, denying approval for a treatment the company had hoped would be a one of its top products in the coming years.
In a letter to the company, the FDA said there were issues with Valeant’s pharmacokinetic data for Duobrii, a lotion intended to treat plaque psoriasis. According to Valeant, it could take six months or more to respond to questions from the FDA, likely inhibiting the 2018 launch the company had hoped for.
Valeant had dubbed Duobrii one of its “Significant Seven” pipeline drugs the company estimated would bring in $1 billion over the next five years.
Valeant’s CEO said the company will continue working towards gaining approval for Duobrii and plans to meet with the agency to answer questions about the medication.
Read the full Reuters report.