FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report March 31, 1995
DURAMED PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-15242 11-2590026
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
7155 East Kemper Road, Cincinnati, Ohio 45249 (513) 731-9900
(Address of principal executive offices)
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INFORMATION TO BE INCLUDED IN THE REPORT
Items 1, 2, 3, 4, 6 and 8 are not applicable and are omitted from
this Report.
Item 5. Other Events
The Company's press release dated March 31, 1995,
relating to its Abbreviated New Drug Application for
the .625 mg strength of Conjugated Estrogens, is
attached as Exhibit 99.1 hereto and is incorporated
herein by reference.
Item 7. Financial Statements, Pro Forma Financial
Information and Exhibits.
(a) Financial Statements of Business Acquired.
Not Applicable
(b) Pro Forma Financial Information.
Not Applicable
(c) Exhibits.
The following exhibit is filed with this Report on
Form 8-K:
Regulation S-K
Exhibit No. Exhibit
99.1 Press release dated
March 31, 1995
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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.
Date: April 5, 1995 DURAMED PHARMACEUTICALS, INC.
By /s/ Timothy J. Holt
Timothy J. Holt
Vice President-Finance
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Exhibit 99.1
PRESS RELEASE
DURAMED COMMENTS ON CONJUGATED ESTROGENS STATUS
FOR IMMEDIATE RELEASE
Cincinnati, OH -- March 31, 1995 -- E. Thomas Arington,
Chairman and Chief Executive Officer of Duramed Pharmaceuticals,
Inc., announced today that Duramed wished to provide information
concerning recent developments in connection with its conjugated
estrogens product.
In September 1994, Duramed filed with the Food and Drug
Administration ("FDA") an Abbreviated New Drug Application for a
generic equivalent to the conjugated estrogens product Premarin
(registered trademark) manufactured by Wyeth-Ayerst. Duramed's
product has been formulated and designed to meet bio-equivalency
guidance established by the FDA in 1991. Since 1991, Wyeth-
Ayerst has made submissions to the FDA requesting that a specific
equine estrogenic substance in Premarin (registered trademark),
Delta 8, 9 DHES, be a required component in conjugated estrogens
drug products. After evaluating Wyeth-Ayerst's request, the FDA
rejected it by letter dated May 31, 1994. FDA concluded that
Delta 8, 9 DHES is an impurity in Premarin (registered trademark)
and nothing more. As previously reported, during late 1994
Wyeth-Ayerst filed a Citizen Petition with the FDA again
requesting the FDA to change the standards for conjugated
estrogens by requiring the generic version to include Delta 8, 9
DHES. The March 20, 1995 edition of the F-D-C- Reports (commonly
known as the "Pink Sheets") noted that Wyeth-Ayerst was enlisting
political support in its attempt to prevent the FDA from
approving a generic version of Premarin (registered trademark)
and described letters sent to the FDA by various present and
former members of Congress.
Duramed understands that, earlier this week, the FDA informed the
Subcommittee on Appropriations of the House Agricultural
Committee that the question of whether Delta 8, 9 DHES should be
required in a generic version of Premarin (registered trademark)
was being referred to one of the FDA's standing Scientific
Advisory Committees.
Mr. Arington stated that it was impossible to predict what
effect, if any, these actions would have on Duramed's product.
Duramed believes that the issues raised by Wyeth-Ayerst's Citizen
Petition have already been addressed by the FDA. Duramed further
believes that its conjugated estrogens product as filed with the
FDA meets the current bio-equivalency guidance as established by
the FDA in 1991.
Duramed Pharmaceuticals, Inc. manufactures and sells generic drug
products comprised of various dosages of prescription and over-
the-counter drugs. The Company's stock is traded on Nasdaq under
the symbol DRMD.
For additional information contact Ellen Knight at Dan Pinger
Public Relations Inc. at (513) 751-6161.
