BUENA, N.J., June 20, 2014 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based generic topical pharmaceutical company, today
announced it has submitted two additional 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 six, with seventeen submissions now pending at the FDA.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "Our team has filed five ANDAs
this week alone, including the ANDA we announced earlier today
under a partnership with Impax Laboratories, Inc. We set
expectations for our team extremely high, and they have proven they
can deliver. We now have seventeen ANDAs pending approval and
on file with the FDA, in addition to four more ANDAs pending
approval under joint development agreements with our
partners. Our 2014 goal of at least ten ANDA submissions
remains on track. We believe our current pipeline of
submissions pending approval by the FDA has a combined addressable
market of over $465 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.