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
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