BAUDETTE, Minn., Oct. 31, 2019 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that
its partner Pharmaceutics International Inc. (Pii) has received FDA
approval of a Prior Approval Supplement for Bretylium Tosylate
Injection, USP 500mg/10ml (50mg/ml). ANI plans to
launch this currently unavailable
drug in December, introducing
this critical drug for the treatment of ventricular
fibrillation and life-threatening ventricular arrhythmias, such as
ventricular tachycardia.
First introduced in 1986, Bretylium Tosylate Injection was added
to the Advanced Care Life Support (ACLS) guidelines and algorithms
recommended by the American Heart Association (AHA) in the
1990s. Due to raw material shortages, the drug has not been
available in the United States
since 1999.
Prior to its discontinuation, Bretylium Tosylate was commonly
stocked as a standard drug on crash carts. ANI estimates that
there are approximately 180,000 crash carts in the U.S. and will
recommend at least two vials of Bretylium
Tosylate per crash cart.
Arthur S. Przybyl, ANI's
President and CEO commented, "We are excited to introduce this
important life-saving cardiac drug and provide physicians with
another valuable tool to treat patients with ventricular
arrhythmias. ANI will be supporting the launch of this drug
with a broad awareness campaign to educate healthcare professionals
on the availability, uses and utility of this important drug."
Dr. Kurt R. Nielsen, President
and CEO of Pii, added, "Partnering with the team at ANI
Pharmaceuticals to develop and supply this uniquely effective
therapy to health care providers and their patients, is further
testament to the value of Pii's Pharmaceutics Know-How™. Pii
will exclusively manufacture Bretylium Tosylate Injection, USP, for
commercialization by ANI."
About Bretylium Tosylate Injection,
USP
Bretylium Tosylate Injection, USP is
indicated in the prophylaxis and therapy of ventricular
fibrillation. Bretylium Tosylate Injection, USP is also
indicated in the treatment of life-threatening ventricular
arrhythmias, such as ventricular tachycardia that have failed to
respond to adequate dose of a first-line antiarrhythmic agent, such
as lidocaine.
Use of Bretylium Tosylate Injection, USP should be limited to
intensive care units, coronary care units or other facilities where
equipment and personnel for constant monitoring of cardiac
arrhythmias and blood pressure are available.
For more information, including the complete list of indications
and usages, please see the Full Prescribing Information.
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.