BUENA, N.J., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted two additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to six, with seventeen submissions now pending at the FDA.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our team has filed five ANDAs this week alone, including the ANDA we announced earlier today under a partnership with Impax Laboratories, Inc. We set expectations for our team extremely high, and they have proven they can deliver. We now have seventeen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with our partners. Our 2014 goal of at least ten ANDA submissions remains on track. We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of over $465 million based on recent data from IMS Health."
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.