BUENA, N.J., Nov. 1, 2013 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based generic topical pharmaceutical company, today
announced it has submitted its fifth 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 thirteen.
(Logo:
http://photos.prnewswire.com/prnh/20130827/MM70487LOGO)
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "This submission brings our
total number of abbreviated new drug applications on file with the
FDA to thirteen. We believe our current pipeline of
submissions pending approval by the FDA has a combined addressable
market of approximately $325 million
based on recent data from IMS Health. The most recent data
indicate that the market dynamics in the topical pharmaceutical
industry continue to be strong. Our successful execution and
continuous expansion of our pipeline will allow us to be well
positioned to fulfill our mission to be a leading player in the
generic topical prescription drug market."
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.