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IGI Laboratories, Inc. Receives Formal FDA Approval for Site Transfer of Econazole Nitrate


11/1/2013 7:16:27 AM

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IGI Laboratories, Inc. Receives Formal US FDA Approval For Site Transfer Of Econazole Nitrate

BUENA, N.J.
, Nov. 1, 2013 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received formal approval from the U.S. Food and Drug Administration (FDA) of its supplemental filing for the site transfer of econazole nitrate cream 1%, to the company's manufacturing facility in Buena, NJ. IGI had purchased econazole nitrate cream 1% from Prasco, LLC in February of 2013.

(Logo: http://photos.prnewswire.com/prnh/20130827/MM70487LOGO)

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This approval marks the first time the FDA has granted an approval to an IGI own-label project. In less than eight months, we successfully completed all the required steps to achieve approval from the FDA to manufacture our first proprietary IGI label product. This accomplishment is a testament to the dedication and efforts of our entire team. We are currently actively manufacturing, marketing and selling this product through our existing commercial infrastructure."

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.

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.

SOURCE IGI Laboratories, Inc.



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