BUENA, N.J., June 2, 2014 /PRNewswire/ -- IGI Laboratories,
Inc. (NYSE MKT: IG), a New Jersey
based generic topical pharmaceutical company, today announced it
has submitted its second abbreviated new drug application (ANDA) in
2014 to the U.S. Food and Drug Administration (FDA), which brings
the Company's total number of ANDA submissions to fifteen, with
thirteen now pending at the FDA.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "We now have thirteen ANDAs
pending approval and on file with the FDA. Our 2014 goal of
at least ten ANDA submissions remains on track. We have set
expectations very high, and we believe June will be the most
productive month for submissions in the company's history.
Our team is focused and prepared to continue to execute. We believe
our current pipeline of submissions pending approval by the FDA has
a combined addressable market of over $370
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.
SOURCE IGI Laboratories, Inc.