BAUDETTE, Minn., June 1, 2020 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) announced
today that it continues to make progress toward addressing items
identified in the Refusal to File letter received from the FDA
relating to its Cortrophin® Gel sNDA filing.
"The most efficient path forward is to concentrate efforts on
the preparation of the resubmission of the sNDA," commented ANI
Pharmaceuticals Interim CEO Patrick
Walsh. "As such, we decided to forego a request for a Type-A
meeting with the FDA and respond to all observations as part of the
comprehensive resubmission of the sNDA. To further support our
efforts, we have retained a prominent regulatory consulting firm to
support the company's re-filing plan, including a comprehensive
review of the entire application before re-submission."
The Company plans on refiling its sNDA for Cortrophin® Gel with
the FDA upon completion of the review process.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing high quality branded and generic
prescription pharmaceuticals. The Company's targeted areas of
product development currently include controlled substances,
oncolytics (anti-cancers), hormones and steroids, and complex
formulations involving extended release and combination products.
For more information, please visit the Company's 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 the company's beliefs regarding its review and
observations relating to its initial Cortophin® Gel sNDA filing,
the company's beliefs concerning its ability to satisfactorily
respond to the matters raised in the FDA's Refusal to File Letter
in a re-submission of the filing, the company's beliefs concerning
the information and activities required to resubmit to the FDA the
Cortophin® Gel sNDA filing, the timing of resubmission of the
company's sNDA to the FDA and the timing and outcome of
the FDA's review of any resubmitted sNDA relating to the Cortophin®
Gel product.
These statements are only predictions and involve known and
unknown risks, uncertainties and other factors, which may cause
ANI's actual results to be materially different from these
forward-looking statements. There can be no assurances that
the results of the additional review and refiling plan will be
successful, that the company will be able to successfully develop
the additional information that may be required for resubmission of
the sNDA, or concerning the timing of completion of development of
any additional information for resubmission of the sNDA. In
addition, there can be no assurance that the FDA will conclude
that any sNDA that the company resubmits will satisfactorily
respond to the matters raised in the FDA's Refusal To File letter,
or concerning the timing of any resubmission by ANI of the sNDA,
that the FDA will approve our sNDA relating to our
Cortophin® Gel product or concerning the timing of any future
action by the FDA on our sNDA, regarding the
commercialization options that the company will pursue if our sNDA
is approved, or that the product will be able to compete
successfully in the market if approved and launched.
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 risks described above or that the
Company may face with respect to importing raw materials; increased
competition; acquisitions; contract manufacturing arrangements;
delays or failure in obtaining product approvals from the U.S. Food
and Drug Administration; general business and economic conditions;
market trends; regulatory environment; 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. 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.