IGI Laboratories, Inc. Announces Eleventh ANDA Submission
July 24 2013 - 4:35PM
Business Wire
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based
generic topical pharmaceutical company, today announced it has
submitted its third abbreviated new drug application (ANDA) in 2013
to the U.S. Food and Drug Administration (FDA), which brings the
Company’s total number of ANDA submissions to eleven.
Jason Grenfell-Gardner, President and CEO of the Company,
commented, "Today’s submission brings our total number of
abbreviated new drug applications on file with the FDA to eleven
which together we believe have a combined addressable market of
approximately $250 million based on recent IMS. Our research and
development team remains on track to deliver on our expectation to
file at least six ANDAs in 2013. We believe that our development
pipeline is the strongest organic driver we have to create long
term value for our shareholders, and we plan to continue to invest
in our research and development efforts to accelerate the growth of
our pipeline. We remain focused on the development of topical
generic pharmaceutical products and are optimistic about the
opportunities in these markets.”
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" 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.
IGI Laboratories, Inc.Jenniffer Collins,
856-697-4379www.igilabs.com
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