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
February 25, 1997
Mallinckrodt Inc.
(Exact name of registrant as specified in its charter)
New York 1-483 36-1263901
(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)
7733 Forsyth Boulevard, St. Louis, MO 63105-1820
(Address of principal executive offices) (ZIP Code)
Registrant's telephone number, (314) 854-5200
including area code
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Item 5. Other Events
A press release was issued February 25, 1997. The relevant portion
of the text of that release was as follows.
(*) Indicates registered trademark
FDA ADVISORY PANEL RECOMMENDS CLEARANCE
OF ALBUNEX* ULTRASOUND IMAGING AGENT
FOR USE IN DIAGNOSING FALLOPIAN TUBE PATENCY
ST. LOUIS, Mo., February 25, 1997 -- Mallinckrodt Inc. (NYSE:MKG)
announced today that the Radiology Device Advisory Panel of the U. S.
Food and Drug Administration (FDA) has voted 7-0 to recommend
clearance of ALBUNEX* [albumin (human), 5%, sonicated], an ultrasound
imaging agent, for use in infertility diagnosis in women. The vote
came yesterday during an advisory panel meeting in Washington. The
specific use voted on by the panel is for diagnosing fallopian tube
patency, which refers to the extent to which the fallopian tube is
open or obstructed.
"We are delighted with the vote of the panel," said Neal L.
Muhilly, imaging vice president-ultrasound for Mallinckrodt. "A
contrast-enhanced ultrasound procedure for diagnosing fallopian tube
patency offers a number of significant advantages to women. It is a
minimally invasive, non-surgical option versus laparoscopy.
Additionally, there would be no exposure to radiation as with an HSG
exam. Finally, the contrast-enhanced ultrasound procedure can be
performed in the privacy of a physician's office under the control of
the woman's gynecologist or reproductive endocrinologist".
ALBUNEX* is a product of Molecular Biosystems, Inc.
Mallinckrodt is the marketer of the product and also has been
responsible for conducting the clinical trials of ALBUNEX* for the
indication of diagnosing fallopian tube patency.
ALBUNEX* is the first ultrasound contrast agent cleared for use in
the United States. Its current indication is for the diagnosis of
cardiac disorders.
Molecular Biosystems, based in San Diego, Calif., is a world
leader in the development of ultrasound contrast agents for medical
imaging. Its shares are listed on the New York Stock Exchange under
the symbol "MB".
Mallinckrodt is a dynamic, international growth company serving
specialty markets in human healthcare and chemicals and is dedicated
to improving healthcare and chemistry. Mallinckrodt is a major
producer of analgesic pharmaceuticals, diagnostic imaging agents,
medical devices, catalysts, and laboratory and microelectronic
chemicals. The St. Louis-based company, with fiscal 1996 net sales
of $2.2 billion, sells more than 2,000 products in more than 100
countries. Mallinckrodt employs about 10,400 people worldwide. The
Mallinckrodt web site can be found at (www.mallinckrodt.com)
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Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: February 25, 1997
