Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Suspension, 0.5%
19 April 2019 - 7:00AM
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 Loteprednol Etabonate Ophthalmic
Suspension, 0.5%. The product is manufactured at Akorn’s
Amityville, New York manufacturing facility.
Douglas Boothe, Akorn’s President and Chief Executive Officer,
stated, “This is a really exciting approval for Akorn as we believe
it is a first generic approval for loteprednol suspension and it
highlights our ability to execute on development and manufacturing
of complex ophthalmic suspensions. I’m also pleased that we
are in the final stages of preparing for commercial launch.”
According to IQVIA, U.S. sales of Loteprednol Etabonate
Ophthalmic Suspension, 0.5% were approximately $89 million for the
twelve months ended February 2019.
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated
for the treatment of post-operative inflammation following ocular
surgery and the treatment of steroid responsive inflammatory
conditions of the palpebral and bulbar conjunctiva, cornea and
anterior segment of the globe such as allergic conjunctivitis, acne
rosacea, superficial punctate keratitis, herpes zoster keratitis,
iritis, cyclitis, selected infective conjunctivitis, when the
inherent hazard of steroid use is accepted to obtain an advisable
diminution in edema and inflammation.
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 commercial launch timing, 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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