Nicox resubmits eye drug to FDA after manufacturing setback
- French pharma Nicox said Mar. 9 it had resubmitted a New Drug Application for its eye medication Zerviate (cetirizine ophthalmic solution) after a contractor fixed manufacturing issues that had led the Food and Drug Administration to reject Zerviate the first go-round.
- Nicox now hopes the drug might be approved by the regulator before the end of 2017, and is actively looking for a commercialization partner in the U.S. The company previously licensed another eye drug it developed, latanoprostene bunod, to Valeant.
- The FDA's complete response letter, issued last October, was tied to a GMP inspection of a contractor in charge of manufacturing Zerviate's active pharmaceutical ingredient cetirizine.
Nicox was one of a number of drugmakers which were tripped up by manufacturing issues last year.
Fourteen complete response letters were issued in 2016, a higher total than the past two years combined. Many of the letters were tied to GMP violations somewhere in the drugmakers' supply chains.
Valeant, Sanofi, Portola, Opko Health and Cempra all had new drug applications rejected over concerns with the manufacturing processes used to the produce their respective drugs.
For Nicox, the issues were at an intermediary contractor that delivered the API to the finished product manufacturer.
Nicox is also hoping Valeant secures an approval for latanoprostene bunod this year, which would give the drugmaker two new revenue streams if Zerviate is also approved.
- Nicox Press release
- BioPharma Dive FDA to drugmakers: Don't let manufacturing lead to rejection
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