BUENA, N.J., Oct. 2, 2015 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based specialty generic pharmaceutical company, today
announced it has submitted its ninth 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 thirty-one.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "As yesterday began the fourth
year of the Generic Drug User Fee Act (GDUFA), this is our first
GDUFA year four submission. We filed thirteen ANDAs in GDUFA
year three. Combined with these filings from GDUFA year
three and forward, these filings represent fifty-four percent
of the total addressable market of our pipeline. We believe
our current pipeline of thirty-one submissions, exclusive of our
four partnered submissions, pending approval by the FDA now has a
combined addressable market of over $1.5
billion based on August 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.
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SOURCE IGI Laboratories, Inc.