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TLGT Teligent Inc

0.1735
0.00 (0.00%)
26 Apr 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Teligent Inc NASDAQ:TLGT NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.1735 0.1721 0.1744 0 01:00:00

IGI Laboratories, Inc. Announces First ANDA Submission Of 2015

26/03/2015 12:00pm

PR Newswire (US)


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BUENA, N.J., March 26, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its first abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-three.

IGI Laboratories logo.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "On March 2, 2015, we committed to file at least twenty ANDAs in 2015.  We believe the ANDA filed today has an addressable market of $20 million based on January 2015 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 $623 million based on January 2015 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-first-anda-submission-of-2015-300056211.html

SOURCE IGI Laboratories, Inc.

Copyright 2015 PR Newswire

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