French pharma Nicox, which specializes in ophthalmic R&D, has been issued a complete response letter from the FDA regarding its cetirizine eye drops after an inspection at a facility that produces the main ingredient.
According to the company, the letter in response to the pending new drug application pertains to “a Good Manufacturing Practice (GMP) inspection at a third party facility producing the active pharmaceutical ingredient (API) cetirizine.” They went on to say that the concerns did not carry over to the finished product facility.
Cetirizine is the active ingredient in Johnson & Johnson’s Zyrtec. Nicox picked up the reformulated ocular itching drug from its now-subsidiary Aciex in 2014 to be used topically in an eye drop, which it is now calling AC-170.
The FDA’s letter comes at a bad time for Nicox, though, because a milestone deadline is fast approaching. If the company were to receive an approval by December this year, it would pick up the milestone payment of $35 million as per an earlier agreement. If it’s after that time, the payout is only $10 million.
Nicox is currently working with its suppliers and the FDA to secure a resubmission of the NDA.