BUENA, N.J., June 26, 2014 /PRNewswire/ -- IGI Laboratories,
Inc. (NYSE MKT: IG), a New Jersey
based generic topical pharmaceutical company, today announced that
it has entered into an agreement with Mallinckrodt LLC,
Mallinckrodt Inc., and Nuvo Research, Inc. (TSX: NRI) (together
Mallickrodt) to settle a declaratory judgment action brought by
IGI, concerning IGI's filing of an abbreviated new drug application
(ANDA) with the U.S. Food and Drug Administration (FDA) seeking
approval to market a generic version of PENNSAID (diclofenac sodium
topical solution) 1.5% w/w. Under the terms of this agreement,
Mallinckrodt granted IGI a
non-exclusive license to launch its diclofenac sodium topical
solution 1.5% product on March 28,
2015. IGI received tentative approval of its diclofenac
sodium topical solution 1.5% from the FDA on May 7, 2014.
Jason Grenfell-Gardner, President
and CEO of the Company, commented, "The agreement provides IGI with
a date certain launch of diclofenac sodium topical solution 1.5%.
We remain confident in our ability to obtain final FDA approval of
our ANDA for diclofenac sodium topical solution 1.5% prior to our
agreed upon launch date. The agreement allows IGI to continue
to expand its portfolio of generic topical prescription drug
products."
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.