8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): March 10, 2016
SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
|
| | |
Delaware | 001-35006 | 93-0979187 |
(State or Other Jurisdiction
of Incorporation) | (Commission
File Number) | (IRS Employer
Identification No.) |
|
| | |
| 11500 S. Eastern Ave., Ste. 240, Henderson, NV | 89052 |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant's telephone number, including area code: (702) 835-6300
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:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
On March 10, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received notification from the U.S. Food and Drug Administration of the grant of approval of the Company’s New Drug Application for EVOMELATM (melphalan) for Injection for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and 2) for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Important Evomela safety information is included attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
|
| | | |
| Exhibit Number | | Description |
| 99.1 | | Important Safety Information for EVOMELA (melphalan) for Injection |
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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| | |
| Spectrum Pharmaceuticals, Inc. |
| | |
Date: March 11, 2016 | By: | /s/ Kurt A. Gustafson |
| | Kurt A. Gustafson |
| | Executive Vice President and Chief |
| | Financial Officer |
Exhibit Index
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| | | |
| Exhibit Number | | Description |
| | | |
| 99.1 | | Important Safety Information for EVOMELA (melphalan) for Injection |