BUENA, N.J., May 7, 2014 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey based generic topical pharmaceutical company, today
announced that it has received tentative approval from the U.S.
Food & Drug Administration (FDA) for its abbreviated new drug
application (ANDA) for diclofenac sodium topical solution,
1.5%.
Diclofenac sodium topical solution, 1.5% is a nonsteroidal
anti-inflammatory drug indicated for the treatment of the pain of
osteoarthritis of the knee. Based on recent IMS Health data,
the total addressable market for this product is approximately
$29 million. IGI originally submitted
this ANDA to the FDA in December
2010.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "This tentative approval marks
the second approval of an IGI ANDA
by the FDA and we believe is a further validation of IGI's
pipeline. The launch of this product will be conditioned on
resolving the patent issues that surround the product. As a result
of this approval, we now have 12 ANDAs pending at the FDA and we
anticipate submitting at least a further nine ANDAs throughout the
remainder of 2014."
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.
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SOURCE IGI Laboratories, Inc.