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news.IGI Laboratories has launched diclofenac sodium 1.5% topical solution, a nonsteroidal anti-inflammatory drug indicated to treat pain from osteoarthritis of the knee.
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The launch of this product follows receipt of the final approval from the US Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA).
IGI Laboratories president and CEO Jason Grenfell-Gardner said: "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.
”We now have twenty-seven submissions, exclusive of our four partnered submissions, pending approval by the FDA, with a combined addressable market of over $939m based on May 2015 data from IMS Health, and another fifteen more submissions planned before the end of this year.
"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."
Currently, the company markets seven products in twelve presentations in an IGI label.
Based on IMS Health data for May this year, the total addressable market for diclofenac sodium 1.5% topical solution is about $13.3m.