FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive
27 Octubre 2008 - 7:12AM
PR Newswire (US)
Duramed to Launch First Lower-Dose, Extended-Cycle Oral
Contraceptive for the Prevention of Pregnancy MONTVALE, N.J., Oct.
27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE:BRL)
today announced that the U.S. Food and Drug Administration (FDA)
has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New
Drug Application (NDA) for LoSEASONIQUE(R) (levonorgestrel/ethinyl
estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets
0.01 mg) extended-cycle oral contraceptive. LoSEASONIQUE(R) is the
first lower-dose, extended-cycle oral contraceptive indicated for
the prevention of pregnancy. Under the LoSEASONIQUE(R)
extended-cycle regimen, women take combination tablets containing
0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84
consecutive days, followed 0.01 mg ethinyl estradiol tablets for
seven days. The regimen is designed to reduce the number of
withdrawal bleeding periods from 13 to four per year. By contrast,
the majority of oral contraceptive products currently available in
the United States are based on a regimen of 21 treatment days,
followed by seven days of placebo. LoSEASONIQUE(R) will be shipped
to trade customers and available by prescription to women in the
first quarter of 2009. Duramed will initiate promotion to
healthcare providers in early 2009 using its sales force and other
marketing initiatives. "As a leader in women's health, Duramed is
committed to continuing to develop new products that provide women
a choice as they discuss birth control options with their
healthcare providers," said Fred Wilkinson, Duramed's Chief
Executive Officer. "We're pleased that the FDA has approved
LoSEASONIQUE(R) as a safe, effective new birth control option for
U.S. women." About LoSEASONIQUE(R) LoSEASONIQUE(R) is a lower dose
extended cycle oral contraceptive indicated for the prevention of
pregnancy. The clinical data supporting the LoSEASONIQUE(R) NDA
resulted from a 12-month, multi-centered, open label clinical trial
that concluded in June 2007. The clinical trial involved over 2,100
female subjects between the ages of 18 and 41 at 56 sites
throughout the United States, and subjects completed an equivalent
of nearly 21,000 28-day cycles of exposure. The most common adverse
events in the clinical trial were headache, irregular and/or heavy
uterine bleeding, dysmenorrhea, nausea and/or vomiting, and back
pain. Important Information About Oral Contraceptives It is
estimated that more than 16 million women currently take oral
contraceptives in the United States. Oral contraceptives are not
for every woman. Serious as well as minor side effects have been
reported with the use of hormonal contraceptives. Serious risks
include blood clots, stroke, and heart attack. Cigarette smoking
increases the risk of serious cardiovascular side effects,
especially in women over 35 years. Oral contraceptives do not
protect against HIV infection (AIDS) and other sexually transmitted
diseases. About Barr Pharmaceuticals, Inc. Barr Pharmaceuticals,
Inc. is a global specialty pharmaceutical company that operates in
more than 30 countries worldwide and is engaged in the development,
manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical
ingredients. A holding company, Barr operates through its principal
subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals,
Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of
companies markets more than 120 generic and 26 proprietary products
in the U.S. and more than 1,200 products globally outside of the
U.S. For more information, visit http://www.barrlabs.com/.
Forward-Looking Statements This communication contains
"forward-looking statements" which represent the current
expectations and beliefs of management of Barr Pharmaceuticals,
Inc. (the "Company") concerning the proposed merger of the Company
with Boron Acquisition Corp., a wholly-owned subsidiary of Teva
Pharmaceutical Industries Ltd. (the "merger") and other future
events and their potential effects on the Company. The statements,
analyses, and other information contained herein relating to the
proposed merger, as well as other statements including words such
as "anticipate," "believe," "plan," "estimate," "expect," "intend,"
"will," "should," "may," and other similar expressions, are
"forward-looking statements" under the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not guarantees of future results and are subject to certain risks
and uncertainties that could cause actual results to differ
materially from those anticipated. Those factors include, without
limitation: the difficulty in predicting the timing and outcome of
legal proceedings, including patent-related matters such as patent
challenge settlements and patent infringement cases; the difficulty
of predicting the timing of FDA approvals; court and FDA decisions
on exclusivity periods; the ability of competitors to extend
exclusivity periods for their products; market and customer
acceptance and demand for our pharmaceutical products; our
dependence on revenues from significant customers; reimbursement
policies of third party payors; our dependence on revenues from
significant products; the use of estimates in the preparation of
our financial statements; the impact of competitive products and
pricing on products, including the launch of authorized generics;
the ability to launch new products in the timeframes we expect; the
availability of raw materials; the availability of any product we
purchase and sell as a distributor; the regulatory environment in
the markets where we operate; our exposure to product liability and
other lawsuits and contingencies; the increasing cost of insurance
and the availability of product liability insurance coverage; our
timely and successful completion of strategic initiatives,
including integrating companies (such as PLIVA d.d.) and products
we acquire; fluctuations in operating results, including the
effects on such results from spending for research and development,
sales and marketing activities and patent challenge activities; the
inherent uncertainty associated with financial projections; our
expansion into international markets through our PLIVA acquisition,
and the resulting currency, governmental, regulatory and other
risks involved with international operations; our ability to
service our significantly increased debt obligations as a result of
the PLIVA acquisition; changes in generally accepted accounting
principles; the reactions of the Company's customers and suppliers
to the merger; and diversion of management time on merger-related
issues. These and other applicable risks, cautionary statements and
factors that could cause actual results to differ from the
Company's forward-looking statements are included in the Company's
filings with the U.S. Securities and Exchange Commission ("SEC"),
specifically as described in the Company's annual report on Form
10-K for the fiscal year ended December 31, 2007. The Company
undertakes no obligation to update or revise any forward-looking
statements to reflect subsequent events or circumstances. Important
Legal Information In connection with the proposed merger, the
Company will prepare a proxy statement to be filed with the SEC.
When completed, a definitive proxy statement and a form of proxy
will be mailed to the stockholders of the Company. Before making
any voting decision, the Company's stockholders are urged to read
the proxy statement regarding the merger carefully and in its
entirety because it will contain important information about the
proposed merger. The Company's stockholders will be able to obtain,
without charge, a copy of the proxy statement (when available) and
other relevant documents filed with the SEC from the SEC's website
at http://www.sec.gov/. The Company's stockholders will also be
able to obtain, without charge, a copy of the proxy statement and
other relevant documents (when available) by directing a request by
mail or telephone to Barr Pharmaceuticals, Inc., 225 Summit Avenue,
Montvale, NJ, 07645 - Attention: Investor Relations. The Company
and its directors and officers may be deemed to be participants in
the solicitation of proxies from the Company's stockholders with
respect to the proposed merger. Information about the Company's
directors and executive officers and their ownership of the
Company's common stock is set forth in the Company's annual report
on Form 10-K for the fiscal year ended December 31, 2007 and the
Company's proxy statement for the Company's 2008 Annual Meeting of
Stockholders. Stockholders may obtain additional information
regarding the interests of the Company and its directors and
executive officers in the merger, which may be different than those
of the Company's stockholders generally, by reading the proxy
statement and other relevant documents regarding the proposed
merger, when filed with the SEC. DATASOURCE: Barr Pharmaceuticals,
Inc. CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, Web Site: http://www.barrlabs.com/ Company News
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