BAUDETTE, Minn., June 30, 2020 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq:ANIP) today announced the
launch of Mexiletine Hydrochloride Capsules USP, 150mg, 200mg and
250mg. The current annual U.S. market for this product is
approximately $16 million, according
to IQVIA/IMS Health.
Patrick Walsh, ANI's Interim
President and CEO, stated, "This is our sixth generic product
launch in 2020. The launch represents an important milestone
for ANI in the integration of our Oakville, Canada manufacturing site, acquired in August
2018. Mexiletine is the first new ANI product launch from the
Oakville site. I congratulate the team in Oakville on
achieving this milestone; we look forward to additional ANI product
launches from this plant in the future."
About Mexiletine Hydrochloride Capsules USP
Mexiletine Hydrochloride Capsules are indicated for the
treatment of documented ventricular arrhythmias, such as sustained
ventricular tachycardia, that, in the judgment of the physician,
are life-threatening. Because of the proarrhythmic effects of
mexiletine, its use with lesser arrhythmias is generally not
recommended. Treatment of patients with asymptomatic ventricular
premature contractions should be avoided.
Initiation of mexiletine treatment, as with other antiarrhythmic
agents used to treat life-threatening arrhythmias, should be
carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in
patients with ventricular arrhythmias.
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, those relating to the development, manufacturing and
commercialization of the product and any additional product
launches from the Oakville, Canada
manufacturing site 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; competition from other
products; 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
("SEC"), including its most recent annual report on Form 10-K and
quarterly reports on Form 10-Q, as well as other filings with the
SEC. 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
View original
content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-announces-launch-of-mexiletine-hydrochloride-capsules-301085595.html
SOURCE ANI Pharmaceuticals, Inc.