ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP
16 Janeiro 2024 - 8:50AM
ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP)
today announced that it received U.S. Food and Drug Administration
(FDA) approval for the Abbreviated New Drug Application (ANDA) for
Indomethacin Oral Suspension (OS), USP.
ANI’s Indomethacin OS is the generic version of
the Reference Listed Drug (RLD) Indocin® Oral Suspension. The
current annual U.S. market for Indomethacin OS is approximately
$4.1 million, according to the latest estimates from IQVIA/IMS
Health, a leading healthcare data and analytics provider.
"With this approval, the FDA has granted
Indomethacin OS a Competitive Generic Therapy (CGT) designation,
with 180-day exclusivity. ANI continues to hold the second highest
number of CGT approvals in the U.S. Generics market, highlighting
the strong capabilities and execution of our Generics R&D team.
We are happy to leverage the CGT pathway to provide our customers
and patients in need with expanded access to high quality generics
for limited competition products,” stated Nikhil Lalwani, President
and Chief Executive Officer of ANI.
About ANIANI Pharmaceuticals,
Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company
serving patients in need by developing, manufacturing, and
marketing high quality branded and generic prescription
pharmaceutical products, including for diseases with high unmet
medical need. Our team is focused on delivering sustainable growth
by scaling up our Rare Disease business through the successful
launch of our lead asset, Purified Cortrophin® Gel, strengthening
our generics business with enhanced research and development
capability, innovation in established brands and leveraging our
North American manufacturing capabilities. 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 commercialization and potential sales of
the product and any additional product launches from the Company’s
generic pipeline, 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 and other
ingredients and supplies necessary for manufacture of our products;
delays or failure in obtaining and maintaining product approval
from the U.S. Food and Drug Administration (“FDA”); changes in
policy or actions taken by the FDA and other regulatory agencies,
including drug recalls; the ability of our manufacturing partners
to meet our product demands and timelines; acceptance of our
products at levels that will allow us to achieve profitability; the
level of competition we face and the legal, regulatory and/or
legislative strategies employed by our competitors to prevent or
delay competition from generic alternatives to branded products;
the impact of legislative or regulatory reform on the pricing for
pharmaceuticals products; issues with product quality,
manufacturing or supply, or patient safety issues; general business
and economic conditions, including the ongoing impact of and
uncertainties regarding the COVID-19 pandemic and inflationary
pressures as well as geopolitical conditions, including the
conflict between Russia and Ukraine.
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.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
Source: ANI Pharmaceuticals, Inc.
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