BUENA, N.J., Nov. 24, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted an 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 seven, with eighteen submissions now pending at the FDA.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our team here at IGI has continued to deliver on the development front. We now have eighteen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with our partners. This should be the first of several ANDAs we file in this quarter, as we plan to file another three to four ANDAs before the end of 2014. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA has a combined addressable market of over $470 million based on recent data from IMS Health."
About IGI Laboratories, Inc.
IGI Laboratories is a specialty generic drug development and manufacturing company. Our mission is to be a leading player in the specialty generic prescription drug market.
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.