BioCentury | Jul 7, 2017
Finance

Onward and upward

...NASDAQ:NBIX) FDA approves Ingrezza valbenazine to treat tardive dyskinesia Nicox S.A. (Euronext:COX) FDA approves Zerviate cetirizine...
BioCentury | Jun 2, 2017
Clinical News

FDA approves Nicox’s Zerviate for ocular itching

...Nicox S.A. (Euronext:COX) said FDA approved an NDA for Zerviate cetirizine (AC-170) to treat ocular itching...
...launch in 2018. It has not priced the drug. Zerviate is a topical formulation of cetirizine...
...active ingredient in the antihistamine Zyrtec . Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Zerviate cetirizine...
BioCentury | May 31, 2017
Company News

Nicox’s Zerviate wins FDA nod for ocular itching

...S.A. (Euronext:COX) jumped €2.26 (21%) to €12.85 Wednesday after FDA approved an NDA for Zerviate cetirizine...
...launch in 2018. It has not priced the drug. Zerviate is a topical formulation of cetirizine...
...safety and efficacy from previously approved products. Cetirizine is the active ingredient in the antihistamine Zyrtec...
BioCentury | Mar 10, 2017
Clinical News

Zerviate regulatory update

...Nicox resubmitted an NDA to FDA for Zerviate cetirizine to treat ocular itching associated with allergic...
...third-party production facility (see BioCentury, Oct. 17, 2016 ). Zerviate is a topical formulation of cetirizine...
...S.A. (Euronext:COX), Sophia Antipolis, France Product: Zerviate cetirizine (AC-170) Business: Inflammation Julian Zhu AC-170 Nicox S.A. Histamine H1 receptor (HRH1) cetirizine Zerviate...
BioCentury | Oct 17, 2016
Clinical News

Cetirizine regulatory update

...the letter related “solely” to a GMP inspection at a third-party facility producing AC-170’s API, cetirizine...
...concerns, but Nicox did not provide a timeline. The candidate is a topical formulation of cetirizine...
...the active ingredient in the antihistamine Zyrtec . Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Cetirizine...
BioCentury | Oct 10, 2016
Company News

Nicox's eye drop gets complete response letter

...letter related "solely" to a GMP inspection at a third party facility producing AC-170's API, cetirizine...
...concerns, but Nicox did not provide a timeline. The candidate is a topical formulation of cetirizine...
...safety and efficacy from previously approved products. Cetirizine is the active ingredient in the antihistamine Zyrtec...
BioCentury | Jul 11, 2016
Finance

Rethinking risk

...date 7/23/16 Neurocrine Biosciences Inc. (NASDAQ:NBIX) Valbenazine Tardive dyskinesia Submit NDA 2H16 Nicox S.A. (Euronext:COX) Cetirizine...
BioCentury | Jun 27, 2016
Clinical News

Cetirizine regulatory update

...allergic conjunctivitis. The PDUFA date is Oct. 18. The product is a topical formulation of cetirizine...
...from the scientific literature or previously approved products. Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Cetirizine...
BioCentury | Jun 22, 2016
Company News

Priority Review for Nicox's eye drop

...cetirizine, to treat ocular itching associated with allergic conjunctivitis. Its PDUFA date is Oct. 18. Cetirizine...
...safety and efficacy from previously approved products. Cetirizine is the active ingredient in the antihistamine Zyrtec...
BioCentury | Apr 25, 2016
Clinical News

Cetirizine regulatory update

...to treat ocular itching associated with allergic conjunctivitis. The product is a topical formulation of cetirizine...
...from the scientific literature or previously approved products. Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Cetirizine...
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