BAUDETTE, Minn., June 2, 2015 /PRNewswire/ -- ANI Pharmaceuticals,
Inc. ("ANI") (NASDAQ: ANIP) today announced that it has received
approval from the U.S. Food and Drug Administration (FDA) of its
Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride
Oral Solution 5mg/5mL. Trailing twelve-month sales for the product
are $30 million, according to IMS,
with three current competitors. ANI expects to begin shipping to
its customers shortly.
Arthur S. Przybyl, President and
CEO of ANI Pharmaceuticals, stated, "This ANDA represents ANI's
first in the area of pain management and our first
internally-developed product to receive approval. Pain management
represents a strategic focus for the Company and ANI's development
pipeline includes several other products in that category."
ANI has forty-six generic drug products under development
addressing a total annual market size of approximately $3.3 billion, based on data from IMS Health.
About Oxycodone Hydrochloride Oral Solution
Oxycodone Hydrochloride Oral Solution 5mg/5mL is an opioid
agonist indicated for the management of moderate to severe pain
where the use of an opioid analgesic is appropriate.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. For more information, please
visit our website www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about price increases, the Company's future
operations, products financial position, operating results and
prospects , the Company's pipeline or potential markets therefor,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; increased competition; delays
or failure in obtaining product approval from the U.S. Food and
Drug Administration; general business and economic conditions;
market trends; products development; regulatory and other approvals
and marketing.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent annual report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on the Company's
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information about ANI, please contact:
Investor Relations
(218) 634-3608
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.