IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted an additional abbreviated new drug application (ANDA) to the US FDA, which brings the company’s total number of submissions to nine.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our first ANDA was submitted to the US FDA in September of 2010, so in less than twenty-eight months we have successfully submitted nine ANDAs. The US FDA reports an average review time of thirty-two months, which makes us believe, we could see our first ANDA approval in 2013. We expect to file at least six ANDAs in 2013, as we are dedicated to expanding our development pipeline, and increasing our IGI product portfolio.”
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.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 "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, including IGI Laboratories, Inc.’s ability to complete the proposed product acquisition. 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.