BUENA, N.J., Dec. 23, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company’s total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.
Jason Grenfell-Gardner, President and CEO of the Company, commented, “In February of 2014, we committed to file ten ANDAs in 2014. After today’s ANDA submissions, we have submitted eleven applications to the FDA in 2014. I am extremely proud of the dedication and accountability of our team- we made commitments and we delivered. Our TICO strategy is focused on the topical, injectable, complex and ophthalmic prescription markets. The topical development engine is running smoothly, and we expect to average one to two topical ANDA submissions per month in 2015. We believe the three ANDAs filed today have a combined addressable market of $39 million based on October 2014 data from IMS Health. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $551 million based on October 2014 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.
Logo - http://photos.prnewswire.com/prnh/20130827/MM70487LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/igi-laboratories-inc-announces-three-additional-anda-submissions-300013411.html
SOURCE IGI Laboratories, Inc.
Help employers find you! Check out all the jobs and post your resume.
