IGI Laboratories, Inc. Announces Second ANDA Submission Of 2015

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Apr 28, 2015, 04:05 ET

BUENA, N.J., April 28, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its second abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-four.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "We believe the ANDA filed today has an addressable market of approximately $50 million based on February 2015 data from IMS Health. We believe our current pipeline of twenty-four submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $702 million based on February 2015 data from IMS Health."

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.