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) September 5, 2012
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| | |
| 000-23265 | | 94-3267443 |
(Commission File Number) | | (IRS Employer ID Number) |
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
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 September 5, 2012, Salix Pharmaceuticals, Ltd. issued a press release announcing that the Food and Drug Administration advised the Company that its New Drug Application for crofelemer 125 mg tablets is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act goal date of September 5, 2012. A copy of this press release is attached as Exhibit 99.1.
On September 5, 2012, the Company issued a press release announcing that five presentations will occur during The National Conference on Pain for Frontline Practitioners. A copy of this press release is attached as Exhibit 99.2.
| Item 9.01. | Financial Statements and Exhibits. |
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | Press release regarding the Food and Drug Administration review of crofelemer dated September 5, 2012. |
| |
| 99.2 | | Press release regarding The National Conference on Pain for Frontline Practitioners dated September 5, 2012. |
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 thereunto duly authorized.
| | |
| | SALIX PHARMACEUTICALS, LTD. |
| |
| Date: September 7, 2012 | | |
| |
| | /s/ Adam C. Derbyshire |
| | Adam C. Derbyshire |
| | Executive Vice President and Chief Financial Officer |
