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Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company’s abbreviated new drug application (ANDA) for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL.
Cypress’ Cetirizine HCl Oral Solution is the AA-rated generic equivalent to McNeil Consumer Healthcare’s Zyrtec® Oral Solution. Generic soma pills no prescription The prescription version of Cetirizine HCl Oral Solution is used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age, and for chronic urticaria (hives) in children 6 months to 5 years of age. The over-the-counter version of Cetirizine HCl Oral Solution is an antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies for individuals 2 years and older and for the relief of itching due to hives for individuals 6 years and older.
Cypress’ Cetirizine HCl Oral Solution will be available through all the national drug wholesalers and chain drug stores and will begin shipping immediately.
About Cypress Pharmaceutical, Inc.
Cypress Pharmaceutical, Inc., founded in 1993, is a specialty pharmaceutical company that develops, markets and distributes generic prescription pharmaceutical products to leading national pharmaceutical wholesalers, chain drug stores, distributors, and other retail merchandisers. In 1999, Cypress established a specialty branded business, Hawthorn Pharmaceuticals, to market a line of internally developed pharmaceutical products directly to physician specialties through its nationwide sales force.
Cypress has an aggressive product development pipeline including new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with over 35 products in various stages of development. Cypress currently has 13 submissions with the Food and Drug Administration (FDA) with up to 8 submissions expected to be filed in 2008.
Cypress and Hawthorn have successfully signed several in-licensing agreements with multinational companies in the past several years and will continue to utilize strategic alliances as part if it’s overall pharmaceutical pipeline.

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Allergic reactions to latex happen commonly in medical settings, where rubber gloves are in abundant supply. But less-visible elements in other environments can also pose danger, according to the American Academy of Allergy, Asthma & Immunology (AAAAI).
"Consider that restaurant meals are frequently prepared by cooks wearing latex gloves. In schools, the cafeteria may be a threat, but there is also potential exposure to latex in school supplies," said Donald H. Beezhold, PhD, FAAAAI, chair of the AAAAI Latex Allergy Committee. "This type of inadvertent exposure poses a serious health risk to millions of Americans."
Estimates of latex allergy prevalence vary, but the condition disproportionately affects healthcare workers and others with frequent exposure to latex - including those who have had multiple surgeries. At least 10 percent of healthcare workers and more than half of individuals with spina bifida are believed to have the allergy, versus 1 percent to 6 percent of the general population.
Reactions to latex can result in skin irritation or anaphylaxis - which can be life-threatening.
Avoidance is key to preventing an allergic reaction and the responsibility of education often falls to the patient. The AAAAI offers resources on latex allergy in the Diseases 101 section of its Web site, The AAAAI recommends these tips for latex-allergic patients:
- Avoid contact with latex products, including gloves, balloons and condoms.
- Inform your doctors, dentist, family, employer and school personnel of the allergy and request accommodations as needed.
- Remember that the federal Americans with Disabilities Act provides workplace protections for individuals with latex allergy. If protective gloves are required for your job, your employer should consider an alternative synthetic material, which is equally effective in most situations.
- Ask your physician if you should wear a medical bracelet identifying your allergy.
Generic ultram pills no prescription An allergist/immunologist is the best-qualified medical professional to diagnose and treat latex allergy and other allergic diseases. To locate an allergist/immunologist in your area, visit the AAAAI Physician Referral Directory.
The American Academy of Allergy, Asthma & Immunology represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has nearly 6,500 members in the United States, Canada and 60 other countries.
American Academy of Allergy, Asthma & Immunology
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Johns Hopkins scientists report that high levels of a noxious gas from stoves can be added to the list of indoor pollutants that aggravate asthma symptoms of inner-city children, especially preschoolers.
Generic cipro pills no prescription Nitrogen dioxide (NO2), an irritating and toxic form of nitrogen oxide gas, is most prevalent in industrial zones but also found at higher levels in poor homes with unvented gas stoves.
In a report in the October issue of Environmental Health Perspectives, Hopkins researchers say asthma flare-ups were directly related to high concentrations of NO2 in the inner city homes they studied.
Specifically, the researchers compared the frequency and intensity of coughing, wheezing, shortness of breath and chest tightness to NO2 levels inside the inner-city homes of 150 Baltimore City 2- to 6-year-olds. Eighty-three percent of the households had gas stoves, 72 percent were heated by natural gas, and 14 percent used gas stoves for heating in the winter. Forty-two percent of the households had annual incomes under $25,000.
Across the board they found that the pollutant worsened day and night symptoms. Each 20-point increase in nitrogen dioxide levels led to 10 percent more days of cough and 15 percent more days with limited speech due to wheezing.
Use of gas stoves, space heaters or home heating with a stove or an oven, either in combination or alone, each drove up nitrogen dioxide concentrations.
"Because using stoves as heat sources is a hallmark of urban poverty, our study tellingly points to how profound and direct the effects of purely social and environmental factors can be on a child’s health," says Johns Hopkins lung expert Nadia Hansel, M.D., a lead researcher on the report.
"Doctors caring for children with asthma should always inquire about the home’s heating and cooking appliances and urge those using gas-based stoves and space heaters to switch to electric heating and cooking, if possible, or at least properly vent the exhaust gases.
"Inner-city preschoolers appear especially vulnerable because they spend most of their time indoors and in homes with high levels of nitrogen dioxide," says study senior investigator and Hopkins pulmonary expert Gregory Diette, M.D. "We knew that but still we were disturbed by what we saw: As nitrogen dioxide levels crept up, so did the frequency and severity of these kids’ symptoms."
Asthma is the most common pediatric chronic illness, affecting 6.2 million children in the United States. Severe illness is most prevalent in inner-city children, doctors say, because of poor access to regular health care and disproportionate exposure to indoor allergens such as mouse and cockroach dander, dust, cigarette smoke and automobile fumes.
In an earlier study of inner-city children with asthma, Johns Hopkins Children’s researchers found even mild asthma among this vulnerable group appears to be more unpredictable than ever, with recommendations for at least four check-ups a year in such children to ward off dangerous flare-ups. Current asthma guidelines call for follow-up of one to six months after diagnosis. For more information, visit Hopkins Children’s Allergy and Immunology division.
Co-investigators in the study: Patrick Breysse, Elizabeth Matsui, M.D. M.H.S; Meredith McCormack, Jean Courtin-Brosnan, D’Ann Williams, Jennifer Moore and Jennifer Cuhran, all of Hopkins.
The research was funded by the National Institute of Environmental Health Sciences, the National Heart, Lung and Blood Institute and the U.S. Environmental Protection Agency.
Johns Hopkins Medicine

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The level of knowledge and understanding of children with food allergies varies significantly across three key groups: pediatricians and family physicians, the general public and families who have a child with food allergies. The article describing the new findings was published in the September issue of BioMed Central Pediatrics.
The research group, led by Ruchi Gupta, MD MPH, assistant professor of pediatrics at Northwestern University Feinberg School of Medicine and Children’s Memorial Research Center, found that misconceptions around food allergy are prevalent among the general public; parents have good knowledge but face many daily challenges; and that physicians differ in their approach to diagnosis and advice for children with food allergies.
The results show that parents of children with food allergies have solid knowledge but experience high levels of anxiety as they worry about their children eating the wrong foods. As one mother said "You are so fearful of anaphylaxis and death. It is this kind of unknowing, this uncertainty of what degree of reaction it’s going to be." Parents felt food allergies impacted every aspect of their lives, including daily functioning, relationships, work and marriage. As one father put it, "My wife is much more into 100 percent prevention all the time and I am more into trying to maximize what my son can do." Many mothers felt their careers suffered or stopped due to the need to protect their child from harmful foods at all meal times.
generic lasix online buy Physicians had basic knowledge of food allergies and anaphylaxis but differed on their approach to diagnosis and the advice they offered families about breastfeeding and introduction of solids. The general public varied in its knowledge of the symptoms and triggers of food allergies. They also tended to overestimate food allergy prevalence and were inclined to over diagnose food allergies in themselves and in their children. As one person put it, "I really think every single person has an allergy they do not know about." As for quality of life — one mother stated, "One of my daughter’s friends is allergic to nuts, and I have to be very careful when we have her over for a play date."
This study helped develop a survey about knowledge, attitudes and beliefs for parents of children with food allergy, physicians and the general public. The surveys were validated and reviewed. This set of studies will help increase knowledge around food allergy in three very important groups to improve the health and lives of children and families with food allergy.
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Article adapted by Medical News Today from original press release.
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The study was supported by grants from the Food Allergy Project which was created by the Bunning Food Allergy Center at Children’s Memorial Research Center and Children’s Memorial Hospital. In 2003, Denise and David Bunning, whose two sons suffer from severe, life-threatening food allergies established the foundation with an $8.5 million, five-year, multi-center food allergy program. The Bunnings have long been committed to advancing education, awareness and research of the growing prevalence of food allergies in children.
Children’s Memorial Research Center is the research arm of Children’s Memorial Hospital, the pediatric teaching hospital of Northwestern University’s Feinberg School of Medicine and one of a small number of institutions in the US that focuses primarily on pediatric research.
Source: Julie Pesch
Children’s Memorial Hospital
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Circassia Ltd, a
specialty biopharmaceutical company focused on controlling immune system
responses, announced positive results from a phase II clinical study
of its anti-allergy technology, ToleroMune(R), in the field of cat allergy.
The trial showed that ToleroMune treatment can substantially reduce
allergic reactions to the allergen that causes most cat allergies, and
importantly was well tolerated by all patients.
Circassia conducted the double-blind study in Germany, where patients
with a confirmed history of cat allergies received a single dose of
ToleroMune therapy or placebo. The 88 study participants were divided into
groups, with each receiving a different dose, either via subcutaneous or
intradermal injection to compare the two routes of administration. To test
the effect of the treatment, patients received a microscopic dose of cat
dander (the main allergen responsible for cat allergies) into their skin
several weeks later. Patients who received ToleroMune therapy via the most
effective administration route had markedly reduced skin reactions to the
cat allergen at all of the five dose levels tested compared with placebo.
The most effective dose reduced reactions by over 40%, compared with 10%
for placebo. Throughout the study the ToleroMune treatment proved well
tolerated, with no serious or severe adverse events experienced in any of
the groups, despite the steadily increasing doses.
"These results are extremely encouraging, both for Circassia and the
huge number of people who suffer from allergies. Current treatment options
address the symptoms only or require repeated administrations over many
months under specialist supervision because of the potential for serious
and even life-threatening side effects, which is a particularly important
issue for cat allergy therapies. Therefore, achieving a marked reduction in
allergic responses after just a single dose is remarkable, and we aim to
build on this by testing short treatments of several doses in future
trials," said Steve Harris, Circassia’s CEO. "Our goal for ToleroMune is to
provide a range of allergy therapies that effectively and quickly treat the
underlying disease while also offering excellent safety. Consequently,
these positive clinical results will not only contribute to the development
of our cat allergy product, but will also provide the foundations for our
other allergy programmes that utilize our ToleroMune technology."
In addition to their potential clinical benefits, Circassia’s
anti-allergy products would have significant market opportunities.
Currently, over 150 million people suffer from allergic rhinitis in the US
and Europe and the market for current treatments, despite their
limitations, is approximately $12 billion per year. The prevalence of
cat-dander allergy is high, with 1-in-6 Americans and nearly 10% of
Europeans suffering from the condition. Existing treatments have a number
of issues, either providing symptomatic relief only or requiring lengthy
supervision by specialist physicians. In contrast, Circassia’s ToleroMune
technology has the potential to rapidly desensitize sufferers using
extremely small sections of allergens (termed T-cell epitopes), which
minimizes the potential for adverse reactions.
About Circassia
Circassia is a specialty biopharmaceutical company focused on
developing medicines designed to control immune system responses. The
company has a highly experienced management team with a proven track record
in product development and commercialization, and having successfully
completed two fundraising rounds is backed by a syndicate of world-class
venture capital and institutional investors, including Imperial
Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.
Circassia’s lead products target allergies utilizing the company’s
proprietary T-cell epitope desensitization technology, ToleroMune. The
company is also developing its ToleroTrans organ anti-rejection technology,
which uses a similar approach to down-regulate immune responses in
transplant patients.
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