BUENA, N.J., Dec. 23, 2014 /PRNewswire/ -- IGI Laboratories,
Inc. (NYSE MKT: IG), a New Jersey
based specialty generic pharmaceutical company, today announced it
has submitted three additional abbreviated new drug applications
(ANDAs) to the U.S. Food and Drug Administration (FDA), which
brings the Company's total number of ANDA submissions in 2014 to
eleven, with twenty-two submissions now pending at the FDA.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "In February of 2014, we
committed to file ten ANDAs in 2014. After today's ANDA
submissions, we have submitted eleven applications to the FDA in
2014. I am extremely proud of the dedication and
accountability of our team- we made commitments and we
delivered. Our TICO strategy is focused on the topical,
injectable, complex and ophthalmic prescription markets. The
topical development engine is running smoothly, and we expect to
average one to two topical ANDA submissions per month in
2015. We believe the three ANDAs filed today have a combined
addressable market of $39 million
based on October 2014 data from IMS
Health. We believe our current pipeline of submissions,
exclusive of partnered submissions, pending approval by the FDA now
has a combined addressable market of over $551 million based on October 2014 data from IMS Health."
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.