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IGI Laboratories, Inc. Announces FDA Approval And Commercial Launch Of Diclofenac Sodium, 1.5%


IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey-based specialty generic pharmaceutical company, today announced it has launched its seventh product, diclofenac sodium 1.5% topical solution, after receipt of the final approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The Company now markets seven products in twelve presentations in an IGI label.

Diclofenac sodium topical solution 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain from osteoarthritis of the knee. Based on IMS Health data for May 2015, the total addressable market for this product is approximately $13.3 million. IGI originally submitted this ANDA to the FDA in December 2010.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "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 $939 million 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."


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