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): March 2, 2015
PACIRA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-35060 |
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51-0619477 |
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(State or other jurisdiction |
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(Commission |
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(IRS Employer |
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of incorporation) |
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File Number) |
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Identification No.) |
5 Sylvan Way, Suite 300, Parsippany, New Jersey 07054
(Address of principal executive offices) (Zip Code)
(973) 254-3560
Registrant’s telephone number, including area code
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 Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
Pacira Pharmaceuticals, Inc. today announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following a review of its supplemental New Drug Application (sNDA) for the use of EXPAREL® (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia. Pacira will immediately schedule an End-of-Review meeting with the Division of Anesthesia, Analgesia and Addiction Products of the Center for Drug Evaluation and Research to discuss the contents of the CRL.
A copy of the press release relating to this announcement is attached as exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit |
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Description |
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99.1 |
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Press Release, dated March 2, 2015. |
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.
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Pacira Pharmaceuticals, Inc. | |
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Date: March 2, 2015 |
By: |
/s/ James Scibetta |
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James Scibetta |
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Senior Vice President and Chief Financial Officer |