BUENA, N.J., June 19, 2014 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based generic topical pharmaceutical company, today
announced it has submitted another abbreviated new drug application
(ANDA) to the U.S. Food and Drug Administration (FDA), which brings
the Company's total number of ANDA submissions in 2014 to four,
with fifteen submissions now pending at the FDA.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "After this submission, we have
now filed seventeen ANDA filings since the end of 2010, and we have
fifteen pending approval and on file with the FDA. We are on
track to meet our goal of at least ten ANDA submissions in
2014. This is our third submission this month, and we still
plan to add to our pending submissions this week. We believe
our current pipeline of submissions pending approval by the FDA has
a combined addressable market of over $420
million based on recent data from IMS Health."
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.
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SOURCE IGI Laboratories, Inc.