Tag: Cetirizine

October 11, 2016 Off

FDA’s approval of NIcox’s cetirizine eye drop formulation triggers $35M in NIcox shares

The approval of the AC-170 NDA after December 1, 2016 would trigger a milestone payment of $10 million in Nicox shares to ex-Aciex shareholders or $35 million in Nicox shares if approval of the NDA is received before this date.

October 10, 2016 Off

Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170

By Dino Mustafić

Nicox S.A. the international ophthalmic R&D company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.