0001193125-11-166071.txt : 20110616 0001193125-11-166071.hdr.sgml : 20110616 20110616065113 ACCESSION NUMBER: 0001193125-11-166071 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20110614 ITEM INFORMATION: Other Events FILED AS OF DATE: 20110616 DATE AS OF CHANGE: 20110616 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Pacira Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001396814 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35060 FILM NUMBER: 11914048 BUSINESS ADDRESS: STREET 1: 5 SYLVAN WAY STREET 2: SUITE 125 CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-254-3560 MAIL ADDRESS: STREET 1: 5 SYLVAN WAY STREET 2: SUITE 125 CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: PACIRA INC DATE OF NAME CHANGE: 20080318 FORMER COMPANY: FORMER CONFORMED NAME: Blue Acquisition Corp DATE OF NAME CHANGE: 20070418 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

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): June 14, 2011

 

 

PACIRA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-35060   51-0619477

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

5 Sylvan Way, Suite 125, 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:

 

¨ 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.

On June 14, 2011, Pacira Pharmaceuticals, Inc. (the “Company,” or “Pacira”) announced that the U.S. Food and Drug Administration (“FDA”) has extended the Prescription Drug User Fee Act (“PDUFA”) goal date for its Review of the New Drug Application for EXPARELTM (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.

The FDA requested additional information from Pacira, which the Company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review.

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.

 

    Pacira Pharmaceuticals, Inc.
Date: June 16, 2011   By:  

/s/ James Scibetta

   

James Scibetta

Chief Financial Officer