KING PHARMACEUTICALS, 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): March 12, 2004

King Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

         
Tennessee
(State or other jurisdiction
of incorporation)
  0—24425
(Commission
File Number)
  54-1684963
(IRS Employer
Identification Number)
     
501 Fifth Street, Bristol, Tennessee
(Address of principal executive offices)
  37620
(Zip Code)

Registrant’s telephone number, including area code: 423-989-8000

Not Applicable
(Former name or former address, if changed since last report)


 


 

Item 5. Other Events

     King Pharmaceuticals, Inc., a Tennessee corporation, announced on March 12, 2004 that on March 9, 2004, it received a copy of a letter from the U.S. Food and Drug Administration (“FDA”) to all Abbreviated New Drug Application (“ANDA”) applicants for a generic equivalent to King’s approved product Skelaxin® 400 mg (metaxalone). The letter stated that ANDA applicants may delete the use listed in the FDA’s publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”) for U.S. Patent No. 6,407,128 from their product labeling. Skelaxin® is a muscle relaxant, indicated for the relief of discomforts associated with acute, painful musculoskeletal conditions. On March 12, 2004, King issued a press release regarding the announcement.

Item 7. Financial Statements, Pro Forma Financial Information and Exhibits

     (c)  Exhibits.

       The following exhibits are filed pursuant to Item 601 of Regulation S-K:

Exhibits:

                 
Exhibit                
Number   Description of Exhibit        

 
       
99.1
  Press Release of King Pharmaceuticals, Inc. dated March 12, 2004.

 


 

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.

     Date: March 15, 2004

  KING PHARMACEUTICALS, INC.

  By: /s/ James R. Lattanzi

  James R. Lattanzi
Chief Financial Officer

 


 

Exhibit Index

                 
Exhibit                
Number   Description of Exhibit        

 
       
99.1
  Press Release of King Pharmaceuticals, Inc. dated March 12, 2004.