Current Report Filing (8-k)
June 13 2018 - 4:47PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 13, 2018
Mylan N.V.
(Exact name
of registrant as specified in its charter)
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The Netherlands
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333-199861
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98-1189497
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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Building 4, Trident Place, Mosquito Way,
Hatfield, Hertfordshire
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AL10 9UL
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(Address of Principal Executive Offices)
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(Zip Code)
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+44 (0) 1707 853 000
(Registrants telephone number, including area code)
Check the appropriate box below if the
Form 8-K
filing is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to
Rule 14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to
Rule 14d-2(b) under
the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to
Rule 13e-4(c) under
the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01
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Regulation FD Disclosure.
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Mylan Provides Statement on Generic Advair Diskus
®
On the afternoon of June 13, 2018, we received an update from the U.S. Food & Drug
Administration (FDA) concerning our pending approval for Generic Advair Diskus® that FDA has identified minor deficiencies to be relayed in a Complete Response Letter on June 27, 2018. Because our Abbreviated New Drug Application has
received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the Complete Response Letter.
Upon receipt of the official Complete Response Letter, we will determine what, if any, impact that it could have on our full year 2018 outlook.
This information includes statements that constitute forward-looking statements, including with regard to product approvals and outlook. These
statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed
or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: ability to execute on new product opportunities; any regulatory, legal or other impediments to our or our
partners ability to bring products to market; other risks inherent in product development; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or
our partners businesses; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; the impact of competition; strategies by
competitors or other third parties to delay or prevent product introductions; the effect of any changes in our or our partners customer and supplier relationships and customer purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of the businesses of Mylan or its partners; uncertainties and matters beyond the control of management; and the other risks detailed in Mylans filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.
The information
contained in this Item 7.01 of this Current Report on Form
8-K
shall not be deemed filed with the Securities and Exchange Commission nor incorporated by reference in any registration statement
filed by the Company under the Securities Act of 1933, as amended.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
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MYLAN N.V.
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Date: June 13, 2018
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By:
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/s/ Kenneth S. Parks
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Kenneth S. Parks
Chief Financial
Officer
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