(PR NEWSWIRE) FDA Approves Duramed Pharmaceuticals to Market Triamterene a
FDA Approves Duramed Pharmaceuticals to Market Triamterene and
Hydrochlorothiazide 37.5mg/25mg, Capsules, USP
* Approval Follows Recent Methotrexate Announcement
CINCINNATI, June 21 /PRNewswire/ -- Duramed Pharmaceuticals, Inc.
(Nasdaq: DRMD) today announced that the U.S. Food and Drug Administration
(FDA) has approved its Abbreviated New Drug Application (ANDA) for Triamterene
and Hydrochlorothiazide 37.5mg/25mg Capsules, USP as a diuretic used as an
adjunct to other antihypertensive drugs. The FDA approved Duramed's
Triamterene and Hydrochlorothiazide 37.5mg/25mg Capsules, USP as bioequivalent
to, and therefore therapeutically interchangeable with, Dyazide(R)*, for all
new and refill prescriptions. Annual brand and generic equivalent revenue for
the product in 1998 was approximately $95 million. Duramed expects to begin
marketing the product immediately.
About the Company
Duramed Pharmaceuticals develops, manufactures and markets prescription
drug products. The company's business strategy emphasizes products with
attractive market opportunities and potentially limited competition due to
technological barriers to entry, focusing on women's health and the hormone
replacement therapy market.
On March 24, 1999, the U.S. Food and Drug Administration (FDA) approved
the company's first branded product, Cenestin(TM) (synthetic conjugated
estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor
symptoms. Shipments of Cenestin began on May 12, 1999 and consumers now can
have a prescription filled at many retail outlets. The sales force is in
place and the direct-to-physicians sales effort is expected to commence on
July 6, 1999. The company will be initiating a clinical program to evaluate
Cenestin in additional dosage strengths and for the prevention of
osteoporosis. One important element of these clinical trials -- the bone
marker study that will assess the efficacy of Cenestin in reducing the loss of
bone caused by the menopause -- has begun, and some results are anticipated to
be published as early as this fall.
Duramed's containment manufacturing facility for the production of
hormones -- with enclosed product flow and state-of-the-art environmental
controls -- ensures purity, stability and precise tablet uniformity for
Cenestin and other hormone products. While Duramed's primary focus will be
solid oral dose hormones, the company's other areas of concentration --
controlled release technology and oncology -- continue to represent attractive
market opportunities that will be pursued, as appropriate.
The company's stock is traded on Nasdaq using the symbol DRMD. Additional
information about the company can be found on the World Wide Web at
www.duramed.com .
* Dyazide is a trademark of SmithKline Beecham Inc.
Like all estrogen drug products, Cenestin should not be used in women with
known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia,
undiagnosed abnormal genital bleeding, active thrombophlebitis, or
thromboembolic disorders. Estrogens have been reported to increase the risk
of endometrial carcinoma in postmenopausal women with an intact uterus. The
most common adverse events reported in clinical experience with Cenestin
included headache, insomnia, asthenia, nervousness, paresthesia, and
depression.
The Securities and Exchange Commission (SEC) encourages companies to
disclose forward-looking information so that investors can better understand a
company's future prospects and make informed investment decisions. Due to
changing market conditions, product competition, the nature of product
development and regulatory approval processes, the achievement of forward-
looking statements contained in this press release are subject to risks and
uncertainties. For further details and a discussion of these risks and
uncertainties, see Duramed's SEC filings, including its annual report on Form
1O-K/A.
SOURCE Duramed Pharmaceuticals, Inc.
-0- 06/21/99
/CONTACT: Investor Relations of Duramed Pharmaceuticals, Inc.,
513-731-9900; or Media, Ellen Knight of Dan Pinger Public Relations,
513-564-0700/
/Web site: duramed.com
(DRMD)
CO: Duramed Pharmaceuticals, Inc.; U.S. Food and Drug Administration
ST: Ohio
IN: MTC
SU:
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