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    WOODCLIFF LAKE, N.J., Oct. 2 /PRNewswire-FirstCall/ -- Duramed
 Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:  
 BRL), announced today the launch of its marketing campaign for ENJUVIA(TM)
 for the treatment of moderate-to-severe vaginal dryness and pain with
 intercourse, symptoms of vulvar and vaginal atrophy associated with
 menopause. ENJUVIA(TM) is the first and only oral estrogen approved by FDA
 for the treatment of these specific symptoms associated with vaginal
 atrophy. ENJUVIA, a plant-derived oral estrogen therapy is already approved
 for the treatment of moderate-to- severe vasomotor symptoms (hot flashes
 and night sweats) associated with menopause.
     The launch of this new indication comes in conjunction with the North
 American Menopause Society annual meeting, October 3-6.
     According to the North American Menopause Society (NAMS), an estimated
 10- 40 percent of post-menopausal women suffer from symptoms related to
 vaginal atrophy (1). Two of the most common symptoms of vaginal atrophy are
 vaginal dryness and pain with intercourse (2). The symptoms of vaginal
 atrophy are most commonly associated with the diminished estrogen levels
 that accompany menopause (1). If left untreated, vaginal atrophy may result
 in years of discomfort (1).
     "ENJUVIA has been shown in clinical studies to provide relief of
 moderate to severe vaginal dryness and pain with intercourse, symptoms of
 vulvar and vaginal atrophy associated with menopause. ENJUVIA's indication
 for the treatment of these moderate to severe vaginal symptoms associated
 with menopause affords women and healthcare professionals a new and
 effective treatment option for two of the most common symptoms associated
 with vaginal atrophy," stated James A. Simon, M.D., Clinical Professor of
 Obstetrics and Gynecology at George Washington University and Medical
 Director, Women's Health & Research Consultants. "There is no
 one-size-fits-all treatment for menopausal symptoms and women with symptoms
 should talk to their healthcare professional about finding a therapy that
 is right for them. For moderate to severe hot flashes and night sweats and
 moderate to severe vaginal atrophy, hormone therapy may be appropriate. If
 taking estrogen only for the symptoms of vaginal atrophy, topical treatment
 should be considered."
     In addition to launching the new indication, the 0.9 mg tablet
 strength, approved by FDA in April, will now be added to the existing range
 of tablet dosing strengths which also includes 0.3 mg, 0.45 mg, 0.625 mg
 and 1.25 mg dosing strengths. This new dosage strength provides additional
 options for healthcare professionals and patients initiating oral estrogen
 therapy. Patients should be started at the lowest approved dose of 0.3 mg
 of ENJUVIA daily. Subsequent dosage adjustment (which will differ depending
 on the indication) and periodic reassessment may be made based upon the
 individual patient response. When prescribed solely for the treatment of
 symptoms of vulvar and vaginal atrophy, topical products should be
 considered.
     Sources
 
      (1) Menopause: The Journal of the North American Menopause Society
          Vol. 14, No.3 pp. 357-358
      (2) Bachman Ga, Ebert GA, Burd ID. Vulvovaginal Complaints. In: Lobo RA,
          ed. Treatment of the Postmenopausal Woman: Basic and Clinical
          Aspects. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins;
          1999:195-201
     About Menopause
     Menopause is the time in a woman's life when the menstrual period
 ceases and the ovaries permanently stop releasing eggs. Menopause is
 considered complete when a woman has been without her period for a full
 year. While some women experience no menopausal symptoms, others suffer
 severe symptoms that require treatment. Vasomotor symptoms (night sweats,
 hot flashes) and vaginal symptoms such as vaginal dryness and pain with
 intercourse are common menopausal symptoms. Although the majority of women
 experience "natural" or spontaneous menopause, some women may experience
 menopause due to a medical intervention such as surgery, chemotherapy or
 radiation.
     Important Information About Estrogens
 
     Cardiovascular and other Risks
     Estrogens with or without progestins should not be used for the
 prevention of cardiovascular disease or dementia.
     The estrogen alone substudy of Women's Health Initiative (WHI) study
 reported increased risks of stroke and deep vein thrombosis in
 postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1
 years, respectively, of treatment with oral conjugated estrogens (CE 0.625
 mg) relative to placebo.
     The estrogen-plus-progestin substudy of the WHI reported increased
 risks of myocardial infarction, stroke, invasive breast cancer, pulmonary
 emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of
 age) during 5.6 years of treatment with oral CE 0.625 mg combined with
 medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. The
 Women's Health Initiative Memory Study (WHIMS), a substudy of WHI study,
 reported increased risk of developing probable dementia in postmenopausal
 women 65 years of age or older during 5.2 years of treatment with CE 0.625
 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA
 2.5 mg, relative to placebo. It is unknown whether this finding applies to
 younger postmenopausal women.
     Other doses of oral conjugated estrogens with medroxyprogesterone
 acetate, and other combinations and dosage forms of estrogens and
 progestins were not studied in the WHI clinical trials and, in the absence
 of comparable data, these risks should be assumed to be similar. Because of
 these risks, estrogens with or without progestins should be prescribed at
 the lowest effective doses and for the shortest duration consistent with
 treatment goals and risks for the individual woman.
     About ENJUVIA
     ENJUVIA tablets are indicated for: the treatment of moderate-to-severe
 vasomotor symptoms associated with menopause; and treatment of moderate to
 severe vaginal dryness and pain with intercourse, symptoms of vulvar and
 vaginal atrophy, associated with menopause. When prescribing solely for the
 treatment of moderate to severe vaginal dryness and pain with intercourse,
 topical vaginal products should be considered.
     Patients should be started at the lowest approved dose of 0.3 mg
 ENJUVIA daily. Subsequent dosage adjustment may be made based upon the
 individual patient response. This dose should be periodically reassessed by
 the healthcare provider.
     The most common side effects in the clinical trials were headache,
 pain, nausea, and breast pain. In clinical trials, adverse events that
 occurred at a rate greater than or equal to 5% and greater than placebo,
 regardless of relationship to study drug, included: abdominal pain,
 accidental injury, breast pain, bronchitis, dizziness, dysmenorrhea,
 flatulence, flu syndrome, headache, nausea, pain, paresthesia, rhinitis,
 sinusitis, and vaginitis.
     ENJUVIA tablets should not be used in individuals with any of the
 following conditions: undiagnosed abnormal genital bleeding; known,
 suspected, or history of cancer of the breast; known or suspected
 estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary
 embolism or a history of these conditions; active or recent (e.g. within
 the past year) arterial thromboembolic disease (e.g. stroke, myocardial
 infarction); liver dysfunction or disease; hypersensitivity to its
 ingredients; or known or suspected pregnancy. There is no indication for
 ENJUVIA in pregnancy. There appears to be little or no increased risk of
 birth defects in children born to women who have used estrogens and
 progestins from oral contraceptives inadvertently during early pregnancy.
     Women and healthcare providers who would like to learn more about
 ENJUVIA, including full prescribing information, should visit
 www.ENJUVIA.com.
     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 115 generic and
 25 proprietary products in the U.S. and more than 1,200 products globally
 outside of the U.S.
     Forward-Looking Statements
     Except for the historical information contained herein, the statements
 made in this press release constitute forward-looking statements within the
 meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
 Securities Exchange Act of 1934. Forward-looking statements can be
 identified by their use of words such as "expects," "plans," "projects,"
 "will," "may," "anticipates," "believes," "should," "intends," "estimates"
 and other words of similar meaning. Because such statements inherently
 involve risks and uncertainties that cannot be predicted or quantified,
 actual results may differ materially from those expressed or implied by
 such forward-looking statements depending upon a number of factors
 affecting the Company's business. These factors include, among others: 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 outcome of litigation arising from
 challenging the validity or non- infringement of patents covering our
 products; 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; our ability to complete
 product development activities in the timeframes and for the costs we
 expect; 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 and implementing our new SAP enterprise resource
 planning system; 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; and other risks detailed in our
 SEC filings, including in our Transition Report on Form 10-K/T for the six
 months ended December 31, 2006.
     The forward-looking statements contained in this press release speak
 only as of the date the statement was made. The Company undertakes no
 obligation (nor does it intend) to publicly update or revise any
 forward-looking statements, whether as a result of new information, future
 events or otherwise, except to the extent required under applicable law.
 
 

SOURCE Barr Pharmaceuticals, Inc.

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