Trials & Filings

FDA Approves IGI Site Transfer

Will move cream production to Buena, NJ

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

IGI Laboratories has received formal approval from the FDA of its supplemental filing for the site transfer of econazole nitrate cream 1%, to the company’s manufacturing facility in Buena, NJ. IGI purchased that product from Prasco, LLC in February, 2013. According to RxList.com, econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum,Trichophyton men-tagrophytes, Trichophyton tonsurans, M...

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