Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - SALIX PHARMACEUTICALS LTD | d680701dex991.htm |
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): February 24, 2014
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
| Delaware | 000-23265 | 94-3267443 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 8510 Colonnade Center Drive Raleigh, North Carolina |
27615 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (919) 862-1000
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)) |
Item 8.01. Other Events.
Salix Pharmaceuticals, Ltd. (“Salix” or the “Company”) and Pharming Group NV (“Pharming”) today announced that the Food and Drug Administration has extended the Prescription Drug User Fee Act Action Date to July 16, 2014 for the Company’s Biologics License Application for the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 IU/kg. Salix and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press release dated February 24, 2014. | |
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.
| Date: February 24, 2014 | SALIX PHARMACEUTICALS, LTD. | |||||
| By: | /s/ Timothy J. Creech | |||||
| Timothy J. Creech | ||||||
| Vice President, Finance and Administrative Services | ||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release dated February 24, 2014. | |