BUENA, N.J., March 12, 2014 /PRNewswire/ -- IGI Laboratories,
Inc. (NYSE MKT: IG), a New Jersey
based generic topical pharmaceutical company, today announced it
has received its first approval from the U.S. Food and Drug
Administration (FDA) for an abbreviated new drug application
(ANDA). The FDA has approved IGI's application for lidocaine
hydrochloride USP 4% topical solution.
Lidocaine hydrochloride USP 4% topical solution is indicated for
the production of topical anesthesia of accessible mucous membranes
of the oral and nasal cavities and proximal portions of the
digestive tract. Based on recent IMS Health data, the total
addressable market for this product is approximately $1.8 million. IGI originally submitted this ANDA
to the FDA in May, 2012.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "Today's action by the FDA marks
a true turning point in the transformation of IGI. With our first
drug approval, organically generated from beginning to end within
IGI, we have validated our team's ability to deliver on R&D.
Although this particular drug is the smallest opportunity in our
pipeline, it is an important milestone for demonstrating IGI's
capabilities. With now 13 further applications pending, and at
least nine more filings planned this year, IGI will continue to
execute its R&D plan as part of our goal of being a leading
player in the generic topical pharmaceutical 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.
Logo -
http://photos.prnewswire.com/prnh/20130827/MM70487LOGO
SOURCE IGI Laboratories, Inc.