-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FR/hROM/UfdLBS9ddZLjxUcp5ws7kBv9mhwp9Q88+U4ahG2OzvyQIqlJUVyo5b8H yddZRREScsi3wTDSrWwhVQ== 0000950152-07-002609.txt : 20070327 0000950152-07-002609.hdr.sgml : 20070327 20070327112331 ACCESSION NUMBER: 0000950152-07-002609 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070326 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070327 DATE AS OF CHANGE: 20070327 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MYLAN LABORATORIES INC CENTRAL INDEX KEY: 0000069499 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 251211621 STATE OF INCORPORATION: PA FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09114 FILM NUMBER: 07720200 BUSINESS ADDRESS: STREET 1: 1500 CORPORATE DRIVE STREET 2: SUITE 400 CITY: CANONSBURG STATE: PA ZIP: 15317 BUSINESS PHONE: 724-514-1800 MAIL ADDRESS: STREET 1: 1500 CORPORATE DRIVE STREET 2: SUITE 400 CITY: CANONSBURG STATE: PA ZIP: 15317 FORMER COMPANY: FORMER CONFORMED NAME: FRM CORP DATE OF NAME CHANGE: 19711003 8-K 1 l25402ae8vk.htm MYLAN LABORATORIES, INC. 8-K MYLAN LABORATORIES, INC. 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 26, 2007
MYLAN LABORATORIES INC.
(Exact name of registrant as specified in its charter)
         
Pennsylvania   1-9114   25-1211621
(State or other
jurisdiction of
Incorporation)
  (Commission File
Number)
  (I.R.S. Employer
Identification No.)
1500 Corporate Drive
Canonsburg, PA 15317

(Address of principal executive offices)
(724) 514-1800
(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.
     On March 26, 2007, Mylan Laboratories Inc., a Pennsylvania corporation (the “Company”) was notified that the U.S. District Court for the District of Columbia has enjoined the U.S. Food and Drug Administration (FDA) from approving any additional Abbreviated New Drug Applications (ANDAs) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base) from April 11, 2007 until at least April 13, 2007. A copy of the Court’s order is attached hereto as Exhibit 99.1, and a copy of the Company’s press release dated March 27, 2007, relating to the order is attached hereto as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
     (c) Exhibits.
     
Exhibit No.
  Description
 
   
99.1
  Order of the United States District Court for the District of Columbia (Civil Action No. 07-579 (RUM)), dated March 26, 2007.
 
   
99.2
  Press release of the registrant dated March 27, 2007.
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.
           
    MYLAN LABORATORIES INC.
 
       
 
       
Date: March 27, 2007
  By:   /s/ Edward J. Borkowski
 
       
 
      Edward J. Borkowski
Chief Financial Officer


 

EXHIBIT INDEX
     
Exhibit No.
  Description
 
   
99.1
  Order of the United States District Court for the District of Columbia (Civil Action No. 07-579 (RUM)), dated March 26, 2007.
 
   
99.2
  Press release of the registrant dated March 27, 2007.
EX-99.1 2 l25402aexv99w1.htm EX-99.1 EX-99.1
 

Exhibit 99.1
Case 1:07-cv-00579-RMU Document 6 Filed 03/26/2007 Page 1 of 2
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
             
MYLAN LABORATORIES, INC. et al., :    
 
      :    
 
  Plaintiffs,   :   Civil Action No.: 07-579 (RMU)
 
      :    
 
      :    
 
      :    
 
      :    
MICHAEL LEAVITT, et al., :  
 
      :    
 
  Defendants.   :    
ORDER
     Pending before the court is the plaintiffs’ application for a temporary restraining order (“TRO”) to enjoin the defendant Food and Drug Administration (“FDA”) from issuing approvals for any abbreviated new drug applications (“ANDAs”) for amlodipine besylate. The plaintiffs seek this TRO claiming that they are entitled by statute to a 180-day period of exclusive marketing and sale of the drug’s generic version. They argue that their statutory right to exclusivity will be infringed if the FDA grants ANDAs to other generic drug manufacturers.
     Government counsel has represented to the court that the FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007. Pursuant to this representation, the court need not enjoin agency action during the pendency of this matter at the agency. Government counsel has left open the possibility, however, that the FDA’s April 11, 2007 decision may simply constitute agency approval of the ANDAs. Such an eventuality would frustrate the process now in place for the court to evaluate the pending TRO application.


 

Case 1:07-cv-00579-RMU Document 6 Filed 03/26/2007 Page 2 of 2
     To ensure that all interested parties have the opportunity to advance their positions to the court on this matter prior to the FDA taking final action on the pending drug approvals, it is this 26th day of March, 2007 hereby
     ORDERED that the FDA notify the court of its decision no later than April 11, 2007, and
it is
     FURTHER ORDERED that the FDA is enjoined from taking final agency action (i.e., granting any ANDAs at issue in this matter) from April 11, 2007 until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiffs’ application for a TRO.
     If the FDA decides to grant the ANDAs, the defendants’ opposition to the plaintiffs’ application for a TRO will be due by 9:00 am on April 12, 2007, and the plaintiffs’ reply will be due by 9:00 am on April 13, 2007.
     SO ORDERED.
RICARDO M. URBINA
United States District Judge

2

EX-99.2 3 l25402aexv99w2.htm EX-99.2 EX-99.2
 

Exhibit 99.2
         
FOR IMMEDIATE RELEASE
  CONTACTS:   Patrick Fitzgerald
Kris King
724-514-1800
U.S. District Court Enjoins the FDA from Approving
Additional Amlodipine Besylate ANDAs
PITTSBURGH—March 27, 2007—Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. District Court for the District of Columbia has enjoined the U.S. Food and Drug Administration (FDA) from approving any additional Abbreviated New Drug Applications (ANDAs) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base) from April 11, 2007 until at least April 13, 2007. The FDA has represented to the court that it will be soliciting views of interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007. Mylan triggered its 180 day exclusivity period for all strengths of Amlodipine Besylate when it commercially launched the product on March 23, 2007.
Amlodipine Besylate Tablets are the generic version of Pfizer’s Norvasc® Tablets, which had U.S. sales of approximately $2.7 billion for the 12-month period ending Dec. 31, 2006, according to IMS Health.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products. For more information about Mylan, please visit www.mylan.com.
This press release includes statements that constitute “forward-looking statements,” including with regard to the launch of Amlodipine Besylate Tablets and the duration of market exclusivity. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal proceedings; and the other risks detailed in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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