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AC-170 Approval Status

  • FDA approved: No
  • Brand name: AC-170
  • Generic name: cetirizine
  • Company: Nicox S.A.
  • Treatment for: Conjunctivitis, Allergic

AC-170 (cetirizine) is a second generation antihistamine topical ophthalmic formulation in development for the treatment of ocular itching associated with allergic conjunctivitis.

On October 10 2016, Nicox S.A. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170. The FDA’s stated reason for the CRL pertains solely to a Good Manufacturing Practice (GMP) inspection at the third party facility producing cetirizine, the active pharmaceutical ingredient in AC-170.

Development Status and FDA Approval Process for AC-170

DateArticle
Oct 10, 2016Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170
Jun 21, 2016U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application
Apr 19, 2016Nicox submits New Drug Application for AC-170 to U.S. FDA

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