ARTICLE | Clinical News
FDA approves Nicox’s Zerviate for ocular itching
June 2, 2017 7:19 PM UTC
Nicox S.A. (Euronext:COX) said FDA approved an NDA for Zerviate cetirizine (AC-170) to treat ocular itching associated with allergic conjunctivitis. The approval is Nicox's first in the U.S.
Last October, FDA issued a complete response letter for Zerviate, citing a GMP inspection at a third party facility. The company resubmitted an NDA on March 8 (see BioCentury, Oct. 17, 2016 & March 13, 2017)...
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