April 04, 2013 08:00 AM Eastern Daylight Time
IGI Laboratories, Inc. Announces Tenth ANDA Submission
BUENA, N.J.--(BUSINESS WIRE)--IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic
topical pharmaceutical company, today announced it has submitted its
second abbreviated new drug application (ANDA) in 2013 to the US FDA,
which brings the company’s total number of submissions to ten.
Jason Grenfell-Gardner, President and CEO of the Company, commented,
"With this submission, we remain on target to deliver on our expectation
to file at least six ANDAs in 2013. The fourth quarter of 2013 will mark
the three year anniversary of our first two submissions to the FDA, and
based on the FDA’s current average review time of thirty-two months, we
are hopeful we could receive our first ANDA approval in 2013. Our team
has filed ten ANDAs in just over two years. We believe that our
successful expansion of our development pipeline is the foundation of
our strategy to create long term shareholder value. We will continue to
look for opportunities to accelerate the growth of our product portfolio
through both our research and business development efforts.”
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 "will," “hopeful,” “believe," "continue" or
words of similar meaning. Factors that could cause actual results to
differ materially from these expectations include, but are not limited
to: the inability to meet current or future regulatory requirements in
connection with existing or future ANDAs;; our failure to obtain FDA
approvals as anticipated; our inability to execute and implement our
business plan and strategy;; changes in global political, economic,
business, competitive, market and regulatory factors; and our inability
to complete 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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