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): October 8, 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.
Today, Salix Pharmaceuticals, Ltd. announced that the Food and Drug Administration (“FDA”) granted final approval as of October 7, 2014 for Uceris® (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The FDA had tentatively approved Uceris rectal foam on September 15, 2014, pending expiration of the 45-day waiting period described in section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act. A copy of the press release is attached hereto as exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | Press release, dated October 8, 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.
| | | | | | |
| October 8, 2014 | | | | SALIX PHARMACEUTICALS, LTD. |
| | | |
| | | | By: | | /s/ Timothy J. Creech |
| | | | | | Timothy J. Creech |
| | | | | | Senior Vice President, Finance and Administrative Services |
EXHIBIT INDEX
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | Press release, dated October 8, 2014. |
