Akorn Receives FDA Approval for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC)
April 18 2019 - 4:05PM
Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic
pharmaceutical company, today announced that it received a new
Abbreviated New Drug Application (ANDA) approval from the U.S. Food
and Drug Administration (FDA) for Fluticasone Propionate Nasal
Spray USP, 50 mcg per spray (OTC).
Douglas Boothe, Akorn’s President and Chief Executive Officer,
stated, “We are excited to add to our Fluticasone franchise and
look forward to expanding into the over-the-counter (OTC) market.
Among other private label possibilities, we have a supply agreement
in place for Fluticare® through Innovus Pharmaceuticals, Inc.
(OTCQB Venture Market: INNV).”
Fluticasone propionate nasal spray USP, 50 mcg per spray is
indicated for the temporary relief of hay fever and other upper
respiratory allergies in adult and pediatric patients 4 years of
age and older.
Fluticare® is a registered trademark of Innovus Pharmaceuticals,
Inc.
About AkornAkorn, Inc. is a specialty
generic pharmaceutical company engaged in the development,
manufacture and marketing of multisource and branded
pharmaceuticals. Akorn has manufacturing facilities
located in Decatur, Illinois; Somerset, New
Jersey; Amityville, New York;
Hettlingen, Switzerland and Paonta
Sahib, India that manufacture ophthalmic, injectable and
specialty sterile and non-sterile pharmaceuticals. Additional
information is available on Akorn’s website
at www.akorn.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release includes statements that may
constitute "forward-looking statements", including expectations and
other statements regarding Akorn's expansion into the OTC market
and other goals and plans. When used in this document, the words
“will,” “expect,” “continue," “scheduled,” “plans,” “intend,” and
similar expressions are generally intended to identify
forward-looking statements. These statements are made pursuant to
the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. A number of important factors could cause actual
results of Akorn and its subsidiaries to differ materially from
those indicated by such forward-looking statements. These factors
include, but are not limited to: (i) the effect of the Delaware
court’s recent decision against Akorn on Akorn’s ability to retain
and hire key personnel, its ability to maintain relationships with
its customers, suppliers and others with whom it does business, or
its operating results and business generally, (ii) the risk that
ongoing or future litigation related to the court’s decision may
result in significant costs of defense, indemnification and/or
liability, (iii) the outcome of the investigation conducted by
Akorn with the assistance of outside consultants, into alleged
breaches of FDA data integrity requirements relating to product
development at Akorn and any actions taken by Akorn, third parties
or the FDA as a result of such investigations, (iv) the difficulty
of predicting the timing or outcome of product development efforts,
including FDA and other regulatory agency approvals and actions, if
any, (v) the timing and success of product launches, (vi)
difficulties or delays in manufacturing, and (vii) such other risks
and uncertainties outlined in the risk factors detailed in Part I,
Item 1A, “Risk Factors,” of Akorn’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2018 (as filed with the
Securities and Exchange Commission (“SEC”) on March 1, 2019), and
other risk factors identified from time to time in our filings with
the SEC. Readers should carefully review these risk factors, and
should not place undue reliance on our forward-looking statements.
These forward-looking statements are based on information, plans
and estimates at the date of this report. Akorn undertakes no
obligation to update any forward-looking statements to reflect
changes in underlying assumptions or factors, new information,
future events or other changes.
Investors/Media:(847)
279-6162Investor.relations@akorn.com
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