-----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, HZsgI5l0XFtCALwGkXvw0gabD1uI/yDF8MYUE4hg5AgBn7/21L8sw8mZ7Xbf+f+6 OSS0tkNvZlEjQ3Bh1SDYXg== 0000950152-05-005960.txt : 20050718 0000950152-05-005960.hdr.sgml : 20050718 20050718083146 ACCESSION NUMBER: 0000950152-05-005960 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050715 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050718 DATE AS OF CHANGE: 20050718 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: 05958366 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 j1507401e8vk.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): July 18, 2005 (July 15, 2005)

MYLAN LABORATORIES INC.

(Exact name of registrant as specified in its charter)
         
Pennsylvania
(State or other jurisdiction of
Incorporation)
  1-9114
(Commission File
Number)
  25-1211621
(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 July 15, 2005, the U.S. Food and Drug Administration (the “FDA”) issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches. Mylan Laboratories Inc. has been working with and continues to work with the FDA in connection with this matter. A copy of the FDA’s Public Health Advisory is attached as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(c) Exhibits.

     
Exhibit No.   Description
 
   
99.1
  Public Health Advisory issued by the FDA on July 15, 2005.

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:  July 18, 2005  By:   /s/ Edward J. Borkowski    
    Edward J. Borkowski    
    Chief Financial Officer   
 

2


 

EXHIBIT INDEX

     
Exhibit No.   Description
 
   
99.1
  Public Health Advisory issued by the FDA on July 15, 2005.

3

EX-99.1 2 j1507401exv99w1.htm EXHIBIT 99.1 EX-99.1
 

Exhibit 99.1

FDA Statement

     
FOR IMMEDIATE RELEASE
  Media Inquiries:
Statement
July 15, 2005
  Laura Alvey, 301-827-6242
Consumer Inquiries:
 
  888-INFO-FDA

FDA Issues Public Health Advisory on the Fentanyl Patch

The FDA today issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

For more information, go to:
http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm.

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