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 received formal approval from the U.S. Food and Drug
Administration (FDA) of its supplemental filing for the site
transfer of econazole nitrate cream 1%, to the company's
manufacturing facility in Buena,
NJ. IGI had purchased econazole nitrate cream 1% from Prasco,
LLC in February of 2013.
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Jason Grenfell-Gardner, President
and CEO of the Company, commented, "This approval marks the first
time the FDA has granted an approval to an IGI own-label project.
In less than eight months, we successfully completed all the
required steps to achieve approval from the FDA to manufacture our
first proprietary IGI label product. This accomplishment is a
testament to the dedication and efforts of our entire team.
We are currently actively manufacturing, marketing and selling this
product through our existing commercial infrastructure."
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.