IGI Laboratories, Inc. Completes Filing of Two Product Development ANDAs with the FDA
BUENA, N.J.--(BUSINESS WIRE)-- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it filed two abbreviated new drug applications, or ANDAs, on December 28 and December 31, 2012 in accordance with one of its customer development agreements. The company executed the customer development agreement earlier in 2012, and completed the development of the two topical generic drug products and filing of the related ANDAs by year end. Upon FDA approval, the company will manufacture and package the products in the customer's label.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "In 2012, we successfully filed two ANDAs for our customer in accordance with our development agreement, and an additional three ANDAs with the FDA on our behalf. We also filed 2 510(k) medical device applications for further development customers for products that would also be manufactured at IGI. As we announced a few weeks ago, Dr. Miller has joined our team as our senior vice president of research and development, under his leadership, we believe we will be able to accelerate our development pipeline and file six ANDAs in 2013."
About IGI Laboratories, Inc.
IGI Laboratories is a developer and manufacturer of topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical 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 "will," "expect," "believe," "possible," "one time," "provides an opportunity," "continue" or words of similar meaning. 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. Actual results may differ materially from these expectations due to, among other factors, changes in global political, economic, business, competitive, market and regulatory factors or IGI Laboratories, Inc.'s ability to implement its business strategies,. 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.
IGI Laboratories, Inc.
Jenniffer Collins, 856-697-4379
KEYWORDS: United States North America New Jersey
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