Akorn Receives FDA Warning Letter
June 25 2019 - 7:35AM
Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic
pharmaceutical company, announced that it received a warning letter
from the U.S. Food and Drug Administration (FDA) related to the
inspection of its Somerset, New Jersey manufacturing facility in
July and August of 2018.
Akorn is committed to the highest standards of
quality and compliance, and will continue to work collaboratively
with the FDA to resolve all issues addressed in the warning
letter. The Company will respond to the FDA letter within the
required 15 working days from receipt of the letter.
Douglas Boothe, Akorn’s President and Chief
Executive Officer, stated, “Akorn is committed to resolving the
warning letter in a comprehensive and effective manner. Earlier
this year, Akorn launched a companywide action plan to improve the
timing and effectiveness of our operations, quality systems and
compliance enhancement initiatives, with an emphasis on
transparency and quality. We believe the execution of this action
plan, which has already begun to yield tangible results, will
strengthen and further standardize our quality systems across the
entire Akorn network.”
The Company has full confidence in the quality
of the products manufactured at the Somerset facility and expects
to continue production at the plant.
Cautionary Note Regarding
Forward-Looking StatementsThis press release may include
forward-looking statements about, among other things, the Company’s
expectations regarding quality systems, action plans, operations,
initiatives, continued production of product, and other statements
regarding Akorn's goals and strategy that are subject to
substantial risks and uncertainties which could cause actual
results to differ materially from those expressed or implied by
such statements. These risk factors include, but are not limited
to: (i) the effect of the Delaware court’s recent decision against
the Company on the Company’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 the
Company with the assistance of outside consultants, into alleged
breaches of FDA data integrity requirements relating to product
development at the Company and any actions taken by the Company,
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,
(vii) the Company’s increased indebtedness and compliance with
certain covenants and other obligations under the Standstill
Agreement, which create material uncertainties and risks to its
growth and business outlook, (viii) the Company’s obligation under
the Standstill Agreement to enter into a Comprehensive Amendment
that is satisfactory in form and substance to the Lenders, (ix) the
Company’s obligation under the Standstill Agreement to pay certain
fees and expenses and increased interest margin, (x) such other
risks and uncertainties outlined in the risk factors detailed in
Part I, Item 1A, “Risk Factors,” of the Company’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), detailed in Part II, Item 1A, “Risk Factors,” of the
Company’s Quarterly Report on Form 10-Q for the fiscal quarter
ended March 31, 2019 (filed with the SEC on May 7, 2019) and other
risk factors identified from time to time in the Company’s
subsequent reports on Form 8-K and in other Company filings with
the SEC. Readers should carefully review these risk factors, and
should not place undue reliance on the Company’s forward-looking
statements. These forward-looking statements are based on
information, plans and estimates at the date of this press release.
The Company undertakes no obligation to update any forward-looking
statements to reflect changes in underlying assumptions or factors,
new information, future events or other changes or
developments.
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.
Investors/Media:(847)
279-6162Investor.relations@akorn.com
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