BAUDETTE, Minn., Sept. 11, 2019 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the
launch of Vancomycin HCl for Oral Solution, 250mg per 5mL (the
generic equivalent to ANI's Vancocin® for Oral
Solution). To facilitate ease of administration the drug now
includes a mixed berry taste, can be administered via nasogastric
tube and does not contain any ingredients made with
gluten-containing grain (wheat, barley, rye). The dye-free
product is delivered in a single bottle format requiring simple
reconstitution and offers dosing flexibility achieved through the
availability of three different size bottles: 80mL, 150mL and
300mL. ANI estimates that the current annual U.S. vancomycin
market is approximately $450
million.
Arthur S. Przybyl, ANI's President
and CEO stated, "This launch represents yet another successful
re-commercialization for ANI of a previously discontinued drug and
is our fourth generic product introduction in 2019. Our
launch of Vancomycin for Oral Solution addresses an unmet need in
the treatment of staph and C-diff infections and provides patients,
physicians and pharmacists with a convenient, FDA-approved oral
solution of vancomycin in addition to the currently available
capsule and injectable forms. We are supporting this launch
with an awareness campaign that leverages the existing virtual
marketing infrastructure that we use to support our brand
portfolio.
About Vancomycin for Oral Solution
Vancomycin Hydrochloride for Oral Solution is a
prescription medication administered orally for treatment of
enterocolitis caused by Staphylococcus
aureus (including methicillin-resistant strains) and
antibiotic-associated pseudomembranous colitis caused by
Clostridium difficile. Parenteral administration of
vancomycin is not effective for the above indications; therefore,
Vancomycin Hydrochloride for Oral Solution must be given orally for
these infections. Orally administered Vancomycin Hydrochloride for
Oral Solution is not effective for other types of infection.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of Vancomycin Hydrochloride for Oral
Solution and other antibacterial drugs, Vancomycin Hydrochloride
for Oral Solution should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and susceptibility information
are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
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.