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 9, 2005
Barrier Therapeutics, Inc.
(Exact name of registrant specified in its charter)
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Delaware (State or other jurisdiction of incorporation) | | 000-50680 (Commission File Number) | | 22-3828030 (I.R.S. Employer Identification No.) |
600 College Road East, Suite 3200, Princeton, New Jersey 08540
(Address of principal executive offices)
(609) 945-1200
(Registrant’s telephone number, including area code)
Not Applicable
(Former name and 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:
o | | Written communications pursuant to Rule 425 under the Section Act (17 CFR 230.425) |
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o | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
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o | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240-14d-2(b)). |
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o | | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
TABLE OF CONTENTS
Item 7.01. Other Events and Regulation FD Disclosure.
On December 9, 2005, Barrier Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for Sebazole™(ketoconazole USP 2%) topical gelfor the treatment of seborrheic dermatitis. A copy of the press release is filed herewith and attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits, Pro Forma Financial Information and Exhibits.
(c) Exhibits.
99.1 — Press release, dated December 9, 2005, entitled “Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole™ Topical Gel”
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 hereunto duly authorized.
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| BARRIER THERAPEUTICS, INC. | |
Date: December 9, 2005 | | By: | ANNE M. VANLENT | |
| | Name: | Anne M. VanLent | |
| | Title: | Executive Vice President, Chief Financial Officer and Treasurer | |
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EXHIBIT INDEX
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Exhibit No. | | Exhibit Title |
99.1 | | Press release dated December 9, 2005 issued by Barrier Therapeutics, Inc. |