BUENA, N.J., July 9, 2015 /PRNewswire/ -- IGI
Laboratories, Inc. (NYSE MKT: IG), a New
Jersey-based specialty generic pharmaceutical company, today
announced it has launched its seventh product, diclofenac sodium
1.5% topical solution, after receipt of the final approval from the
U.S. Food and Drug Administration (FDA) for an abbreviated new drug
application (ANDA). The Company now markets seven products in
twelve presentations in an IGI label.
Diclofenac sodium topical solution 1.5% is a nonsteroidal
anti-inflammatory drug indicated for the treatment of the pain from
osteoarthritis of the knee. Based on IMS Health data for
May 2015, the total addressable
market for this product is approximately $13.3 million. IGI originally submitted this ANDA
to the FDA in December 2010.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "Today's action by the FDA
represents our second drug approval for a product organically
developed from beginning to end by our IGI team. In anticipation of
this approval, we have already secured orders from our customers,
and we are ready to fulfill these orders immediately.''
''We now have twenty-seven submissions, exclusive of our four
partnered submissions, pending approval by the FDA, with a combined
addressable market of over $939
million based on May 2015 data
from IMS Health, and another fifteen more submissions planned
before the end of this year. Our team continues to execute our
R&D plan as part of our mission to become a leading player in
the specialty generic prescription drug market."
About IGI Laboratories, Inc.
IGI Laboratories is a specialty generic pharmaceutical
company. Our mission is to be a leading player in the
specialty generic 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.