IGI Laboratories, Inc. Announces Tenth ANDA Submission
BUENA, N.J.--(BUSINESS WIRE)-- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second abbreviated new drug application (ANDA) in 2013 to the US FDA, which brings the company's total number of submissions to ten.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "With this submission, we remain on target to deliver on our expectation to file at least six ANDAs in 2013. The fourth quarter of 2013 will mark the three year anniversary of our first two submissions to the FDA, and based on the FDA's current average review time of thirty-two months, we are hopeful we could receive our first ANDA approval in 2013. Our team has filed ten ANDAs in just over two years. We believe that our successful expansion of our development pipeline is the foundation of our strategy to create long term shareholder value. We will continue to look for opportunities to accelerate the growth of our product portfolio through both our research and business development efforts."
About IGI Laboratories, Inc.
IGI Laboratories is a generic topical pharmaceutical company. We develop and manufacture 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," "hopeful," "believe," "continue" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: the inability to meet current or future regulatory requirements in connection with existing or future ANDAs;; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy;; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete 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.
IGI Laboratories, Inc.
Jenniffer Collins, 856-697-4379
KEYWORDS: United States North America New Jersey
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