BUENA, N.J., March 12, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received its first approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution.
Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on recent IMS Health data, the total addressable market for this product is approximately $1.8 million. IGI originally submitted this ANDA to the FDA in May, 2012.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today's action by the FDA marks a true turning point in the transformation of IGI. With our first drug approval, organically generated from beginning to end within IGI, we have validated our team's ability to deliver on R&D. Although this particular drug is the smallest opportunity in our pipeline, it is an important milestone for demonstrating IGI's capabilities. With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."
About IGI Laboratories, Inc.IGI Laboratories is a generic topical pharmaceutical company. We develop and manufacture topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical prescription drug market.Forward-Looking StatementsThis 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.