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

The Company Now Markets Seven Products in its Topical Portfolio

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Jul 09, 2015, 08:00 ET

BUENA, N.J., July 9, 2015 /PRNewswire/ -- 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."

About IGI Laboratories, Inc.

IGI Laboratories is a specialty generic pharmaceutical company. Our mission is to be a leading player in the specialty generic prescription drug market.

Forward-Looking Statements

This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue," "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in IGI Laboratories, Inc.'s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission. IGI Laboratories, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

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SOURCE IGI Laboratories, Inc.