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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, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Jason Grenfell-Gardner, president and chief executive officer of IGI, commented, “This approval marks the first time the FDA has granted an approval to an IGI own-label project. In less than eight months, we successfully completed all the required steps to achieve approval from the FDA to manufacture our first proprietary IGI label product. This accomplishment is a testament to the dedication and efforts of our entire team. We are currently actively manufacturing, marketing and selling this product through our existing commercial infrastructure.”

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