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IGI Laboratories announces FDA approval, launch of diclofenac

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IGI Laboratories today announced the FDA approval and subsequent launch of the company’s diclofenac sodium 1.5% topical solution.

An NSAID indicated for treating pain stemming from knee osteoarthritis, diclofenac sodium was originally submitted under an abbreviated new drug application to the FDA in December 2010. It represents the company’s seventh product in 12 presentations in an IGI label, according to a company press release.

“Today’s action by the FDA represents our second drug approval for a product organically developed from beginning to end by our IGI team. In anticipation of this approval, we have already secured orders from our customers, and we are ready to fulfill these orders immediately,” Jason Grenfell-Gardner, president and CEO of IGI Laboratories, said in the release. “Our team continues to execute our R&D plan as part of our mission to become a leading player in the specialty generic prescription drug market.”

Reference: www.igilabs.com.