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GMP Issues at API Supplier Cited in Response Letter to Eye Drop Formulator

October 18, 2016

Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170.

The letter is related to a GMP inspection at a third-party facility producing the active pharmaceutical ingredient cetirizine and supplying it to the manufacturer of the finished product. The eye solution is used for the treatment of ocular itching associated with allergic conjunctivitis.

The letter states the safety and efficacy data submitted by Nicox in the AC-170 NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA. Furthermore, the CRL did not include any concerns related to the finished product manufacturing facility.

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