ANI Pharmaceuticals Announces the FDA Approval and Launch of Levocarnitine Tablets USP
20 December 2022 - 8:56AM
Business Wire
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
Levocarnitine Tablets USP, 330 mg.
ANI’s Levocarnitine Tablets are the generic version of the
Reference Listed Drug (RLD) Carnitor®. The current annual U.S.
market for Levocarnitine Tablets is approximately $10.0 million,
according to IQVIA/IMS Health, a leading healthcare data and
analytics provider.
"The launch of Levocarnitine Tablets is another example of ANI’s
commitment to increasing patient access to affordable, high-quality
medicines and aligns with our goal of bringing limited-competition
products to market,” stated Nikhil Lalwani, President and Chief
Executive Officer of ANI.
About ANI
ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical
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 building a successful Purified Cortrophin® Gel franchise,
strengthening our generics business with enhanced 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; competition
from other products; acquisitions; contract manufacturing
arrangements; delays or failure in obtaining and maintaining
product approval from the U.S. Food and Drug Administration;
general business and economic conditions, including the ongoing
impact of and uncertainties regarding the COVID-19 pandemic and
inflationary pressures; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221219005795/en/
Investor Relations: Lisa M. Wilson, In-Site
Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com
Media: Faith Pomeroy-Ward, ANI Pharmaceuticals
817-807-8044 Faith.pomeroyward@anipharmaceuticals.com
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