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)
December 27, 2016
Amphastar Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
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Delaware |
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001-36509 |
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33-0702205 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
11570 6th Street
Rancho Cucamonga, California 91730
(Address of principal executive offices, including zip code)
(909) 980-9484
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
ITEM 8.01. Other Events.
On December 27, 2016, Amphastar Pharmaceuticals, Inc. (“Amphastar”) announced in a press release that the Company received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application for Primatene® Mist (epinephrine inhalation aerosol).
A copy of the press release is being filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
ITEM 9.01.Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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Press Release of Amphastar Pharmaceuticals, Inc. dated December 27, 2016 |
SIGNATURES
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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AMPHASTAR PHARMACEUTICALS, INC. |
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Date: December 27, 2016 |
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By: /S/WILLIAM J. PETERS |
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William J. Peters |
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Chief Financial Officer and Senior Vice President |
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Exhibit Index
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Exhibit No. |
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Description |
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99.1 |
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Press Release of Amphastar Pharmaceuticals, Inc. dated December 27, 2016 |