Cornerstone Therapeutics Inc. (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):   November 22, 2010

Cornerstone Therapeutics Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 000-50767 04-3523569
_____________________
(State or other jurisdiction 		_____________
(Commission 		______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
1255 Crescent Green Drive, Suite 250, Cary, North Carolina   27518
_________________________________
(Address of principal executive offices) 		  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   919-678-6611

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))

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Item 8.01 Other Events.

On November 22, 2010, Cornerstone Therapeutics Inc. (the "Company") announced that it will voluntarily remove three products containing propoxyphene from the U.S. market. The move is in response to the Food and Drug Administration’s consultation and subsequent agreement with Xanodyne Pharmaceuticals, Inc. regarding the voluntary market withdrawal of the brand versions of propoxyphene. Generic manufacturers of propoxyphene-containing products, which include Cornerstone, were requested to voluntarily remove their products as well. The Company's net product sales of the affected products for the nine months ended September 30, 2010 were $8.0 million.

A copy of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference.





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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.

         
    Cornerstone Therapeutics Inc.
          
November 23, 2010   By:   /s/ Andrew K. W. Powell
       
        Name: Andrew K. W. Powell
        Title: Executive Vice President, General Counsel and Secretary

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Exhibit Index


     
Exhibit No.   Description
 
99.1
  Press Release dated November 22, 2010.