BAUDETTE, Minn., April 18, 2018 /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
Morphine Sulfate Oral Solution 10mg/5mL, 20mg/5mL and 100mg/5mL.
The current annual U.S. market for this product is approximately
$17 million, according to Iqvia/IMS
Health. ANI expects to begin shipping product to its customers in
the near future.
Arthur S. Przybyl, ANI's
President and CEO stated, "We are pleased to announce the approval
of this internally developed generic product, which leverages both
our liquid manufacturing and controlled substance capabilities. In
addition to the standard packaging formats, we intend to launch the
product in a unit dose configuration. This represents the sixth
approval of a generic product from our internally developed
pipeline."
About Morphine Sulfate Oral Solution
Morphine Sulfate Oral Solution is indicated for the management
of acute and chronic pain severe enough to require an opioid
analgesic and for which alternative treatments are inadequate.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is
indicated for the relief of acute and chronic pain in
opioid-tolerant patients.
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;
acquisitions; contract manufacturing arrangements; 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
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.