Posted by Reporter on Tuesday
Medicis today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 65mg and 115mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
“We are very pleased to announce the approval of these new strengths of SOLODYN,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “These additional strengths will complement the current SOLODYN lineup to offer physicians more precise weight-based dosing options, and make SOLODYN the first and only extended release minocycline with five FDA-approved dosing strengths. We believe physicians and patients will appreciate the value of this greater dosing precision.”
According to the American Academy of Dermatology, acne is the most common skin disorder in the United States, affecting 40 million to 50 million Americans(1). In 2008, there were over 4.5 million patient visits to dermatologists for acne(2). Greater than 5.3 million prescriptions were written by dermatologists for minocycline, doxycycline and/or tetracycline, totaling approximately $879 million in branded and generic retail dollars. Approximately 28% of the 5.3 million prescriptions were written for branded products(3).
About SOLODYN Extended Release Tablets
Launched to dermatologists in July 2006 after approval by FDA on May 8, 2006, SOLODYN is the only branded oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN was the first approved minocycline in extended release tablet form. Minocycline is lipid soluble, and distributes in the skin and sebum.
The dosing and administration for SOLODYN is based on extensive, multi-year clinical trials conducted by Medicis in which over 1,000 patients participated. The recommended dosage for SOLODYN is 1 mg/kg daily. In Medicis-sponsored studies, higher doses of SOLODYN (2- and 3-mg/kg/day) were tested against 1 mg/kg/day SOLODYN and did not show additional therapeutic benefits in the treatment of inflammatory lesions of acne. Higher doses have not been shown to be of additional benefit, and may be associated with more acute vestibular side effects(4).
SOLODYN has three issued patents. U.S. patent No. 5,908,838 (’838), which expires in 2018, relates to the use of the SOLODYN unique dissolution rate. The Company believes all forms of SOLODYN currently approved for use, including the 65mg and 115mg dosages, are covered by one or more claims of the ‘838 patent. U.S. Patent No. 7,541,347, which expires in 2027, relates to the use of the 90mg controlled-release oral dosage form of minocycline to treat acne. U.S. Patent No. 7,544,373, which expires in 2027, relates to the composition of the 90mg dosage form. The Company has a number of additional U.S. patent applications associated with the SOLODYN program on file at the USPTO, several of which contemplated these additional dosage forms.
With the addition of the strengths announced in this press release, SOLODYN is now available by prescription in the five following extended release tablet dosages: 45mg (NDC #99207-460-10 and NDC #99207-460-30), 65mg (NDC #99207-463-10 and NDC #99207-463-30), 90mg (NDC #99207-461-10 and NDC #99207-461-30), 115mg (NDC #99207-464-10 and NDC #99207-464-30) and 135mg (NDC #99207-462-10 and NDC #99207-462-30). When used as directed, SOLODYN is safe and effective for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The most commonly reported side effects associated with the use of SOLODYN were headache, fatigue, dizziness and pruritus. Minocycline, like other tetracyclines, can cause fetal harm when administered to a pregnant woman. Tetracycline drugs should not be used during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening; therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy, but were not significant in SOLODYN clinical investigations. In rare cases, photosensitivity has been reported. SOLODYN should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child while on therapy; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. SOLODYN is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Safety beyond 12 weeks of use has not been established. Full prescribing information for SOLODYN can be obtained by contacting Medicis. For more information about SOLODYN, visit www.Solodyn.com.
(1) American Academy of Dermatology. “Acne Facts.”
http://www.aad.org/media/background/factsheets/fact_acne.html.
Accessed March 9, 2009.
(2) IMS Health. Quarterly NDTI database. December 2008. Data on file,
Medicis Pharmaceutical Corporation.
(3) IMS Health, NPA 2008.
(4) MP-0104-01, “A Randomized, Double-Blind, Placebo-Controlled
Phase II Dose Ranging Study of an Oral Extended Release
Formulation of Minocycline as Primary Therapy for Acne Vulgaris
in Participants 12-30 Years of Age.”
(5) The LIPOSONIX(R) system is not cleared for sale in the U.S.
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Posted by Reporter on Monday
Until now, all regular body washes caused dry skin damage. Now, Dove has discovered how to restore skin’s natural moisture while cleansing with body wash. Current body washes actually damage proteins and lipids in the skin’s outer layer, often leading to the loss of critical moisture. Recognizing skin lipids require different care than skin proteins, Dove developed its latest liquid cleansing technology called NutriumMoisture. Research published in the June 2009 issue of Cosmetic Dermatology confirms NutriumMoisture is clinically proven to preserve both skin’s natural proteins and lipids while significantly reducing dryness and improving moisturization.
To view Multimedia News Release, go to
http://www.prnewswire.com/mnr/dove/39065/
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The RejuvaStamp Digital “Electro Collagen Induction Therapy” (ECIT) Device, or “Needling” is promised to be the future in skin rejuvenation. This procedure is as effective as laser resurfacing, dermabrasions and chemical peels, but without the side effects. ECIT is a viable alternative to facial surgery and injections. It is a safe non-ablative procedure that works from the inside and out. The RejuvaStamp Digital (ECIT) works beneath the surface of the skin to stimulate collagen growth, tighten, and rejuvenates skin, while keeping the epidermis intact; all without any side effects and faster healing time.
The RejuvStamp makes skin rejuvenation, safe and natural with amazing results. “The RejuvaStamp Digital helps with Acne Scars, Stretch Marks, and Wrinkles” Stated by Claire Marquez, the creator and manufacturer of the RejuvaStamp. “ECIT works by inserting tiny micro needles into the skin creating thousands of perforations. These microscopic perforations stimulate your body’s own natural electrical response. (Just like acupuncture). These natural Electro signals induce your body’s own natural human growth factor (PDGF), to transform into growth factor (TGF beta). This will increase blood circulation to the penetrated area, and stimulate collagen, and elastin production. The new collagen and elastin matrix can continue rejuvenation for up to 12 months.”
RejuvaStamp smoothes wrinkles and expression lines, relaxes scars and improves skin texture and tightness.
The device helps:
- Improves depressed acne scarring
- Improves skin pigmentation
- Improves stretch marks
- Repairs smoker’s lines
- Improve crow’s feet around the eyes
- Smooth and tighten eyelid skin
You can visit www.RejuvaStamp.com to learn more about ECIT, and see their videos.
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Until now, all regular body washes caused dry skin damage. Now, Dove has discovered how to restore skin’s natural moisture while cleansing with body wash. Current body washes actually damage proteins and lipids in the skin’s outer layer, often leading to the loss of critical moisture. Recognizing skin lipids require different care than skin proteins, Dove developed its latest liquid cleansing technology called NutriumMoisture. Research published in the June 2009 issue of Cosmetic Dermatology confirms NutriumMoisture is clinically proven to preserve both skin’s natural proteins and lipids while significantly reducing dryness and improving moisturization.
Dry skin damage caused by cleansing manifests itself as dry, itchy, flaky and tight skin. Some existing body washes address this damage by adding moisturizing ingredients, called occlusives, that sit on top of skin. While these additives help mask dry skin damage, they do not address the deeper problem of lipid damage caused during the cleansing process. Now with the introduction of NutriumMoisture, moisture loss caused by cleansing no longer has to be a skin care concern.
NutriumMoisture: A Breakthrough in the Body Wash Category
NutriumMoisture fuses the mild cleansing benefits of DEFI (Directly Esterified Fatty Isethionate) technology found in the iconic Dove Beauty Bar with a new, unique moisturizing complex that cares for surface skin ten layers deep. Unlike other body washes, this first-of-its-kind body wash technology takes a dual approach to healthy skin by preserving both proteins and lipids during cleansing which is critical for optimal skin health. The formulation is comprised of sodium lauroyl isethionate, a mild cleanser that reduces protein damage, and 100% skin-compatible natural moisturizers, including stearic acid, soybean oil and glycerin, that fully absorb into skin to replenish lipids lost during cleansing.
Dove has been at the forefront of research and breakthrough cleansing technology since the brand’s inception. This dates back to the launch of the Dove Beauty Bar in 1957 which revolutionized the way women cared for their skin by providing the first alternative to soap that was less drying to skin. Now, Dove is once again bringing category-changing technology to the personal wash category.
“For over fifty years, Dove has led innovations in the skin care industry and the introduction of NutriumMoisture technology continues that tradition,” said K.P. Ananth, Unilever principal research scientist. “We are thrilled our extensive research and testing has allowed us to be the first brand to minimize lipid damage with a liquid cleanser in order to provide intensive moisturizing benefits that strengthen and smooth skin.”
NutriumMoisture: Most Effective Natural Nourishment
Dove NutriumMoisture contains the highest level of natural moisturizers in a body wash, making it the most effective natural nourishment ever. While moisturizers in other body washes sit on top of skin, new NutriumMoisture penetrates surface skin deep down to replenish skin where it is needed most. By absorbing into the skin, the moisturizing complex is able to deliver hydration for skin barrier components and processes to help skin maintain a healthy and resilient state.
“This technology represents an important change in the body cleansing paradigm. Until now, body wash products have only masked dry skin damage rather than effectively addressed it,” said Dr. David Leffell, M.D.; professor of dermatology and surgery at Yale University’s School of Medicine. “By targeting skin directly where damage occurs (within the surface layer), NutriumMoisture technology helps build a foundation for the stratum corneum to become stronger and the skin smoother.”
NutriumMoisture: Clinically Proven to Deliver Results
The new Dove Body Wash collection with NutriumMoisture is clinically proven to deliver noticeable results. Results from a four-week clinical study show:
- Significantly reduced dryness and improved moisturization in just three weeks. Both expert visual grading analysis and objective computer image analysis of high-resolution digital images of the subjects before and after three weeks of treatment, confirmed the effects were significant and noticeable.
- Dryness reversed in one week (after switching from regular body wash)
- Softer, smoother skin all over
- More even skin tone
The new NutriumMoisture technology will be offered in Deep Moisture, Sensitive Skin and Gentle Exfoliating variants. The body washes will be available in August 2009 at food, drug, mass and club retailers. For more information visit dove.com.
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Free-Pill.com, The Best Free Stuff Site For Health Products for Men and Women.Get Weight Loss Pills Free, General Health Free Samples, Health and Beauty Free Trials including Skin Care , Teeth Whitening freeibies etc.
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http://nighttimemoisturizers.com
Moisturizer helps to form a fine, protective layer that enables the skin to retain the moisture it requires. Moisturizing is
essential for all types of skin including oily skin. Dry skin and ageing skin derive the maximum benefits from a moisturizer.
Lack of moisture on the skin causes skin to become dry and more prone to wrinkling. Moisturizers come in two forms liquid and
cream. Rich, liquid and cream moisturizers take care of dry and wrinkled skin. Water - based, oil free moisturizer works best
for oily skin. Herbal moisturizers are very light. They not only help to protect the skin but also assist in evaporating
excess of moisture.
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Posted by Reporter on Sunday
If you are here reading my blog, chances are, you struggle with sugar addiction or perhaps may be seeking alternatives to white refined sugars.
I don’t know about you, but at times I’ve felt absolutely powerless against the ragings of my sweet tooth. It’s as if all of the delicious, fattening goodies out there sing out to my sweet tooth like a siren. Sometimes I give in and eat honey or fruit or whip up a batch of naturally sweetened this or that. Other times I try to focus on the project at hand and overpower the lustings of my mouth…..or perhaps, my brain.
I’ve stumbled across some interesting facts about sugar addiction and hopefully the information will shed some light onto why, at times, you must have something sweet. And then a bit more. And more.
From Food Addicts Anonymous website:
“The FAA program is based on the belief that food addiction is a bio-chemical disease. By following a food plan devoid of all addictive substances, we can recover. These substances include sugar, flour, and wheat in all their forms. They also include fats and any other high-carbohydrate, refined, processed foods that cause us problems individually.”
From Michael Pollan in Food, Inc. (which I saw again, yesterday):
“We are eating 100’s of pounds of [sugars] a year. The food industry is pushing our evolutionary buttons.”
From Neal Barnard, M.D. book, Breaking the Food Seduction: “But banishing those cravings for chocolate, cookies, cheese, or burgers isn’t a question of willpower, it’s a matter of biochemistry.”
From Marion Nestle’s What To Eat: “If you cannot help liking sweet foods, it is for a good reason. Humans are born with a predilection for sweetness to stimulate sucking reflexes. Breast milk is sweet because it contains lactose, a double sugar of glucose and galactose. So it is normal to like sweet foods.”
From David Kessler’s The End of Overeating: “The combination of sugar and fat is what people prefer, and it’s what they’ll eat most.”
“Many of us have what’s called a ‘bliss point’–the point at which we get the greatest pleasure from sugar, fat, or salt. Scientists depict this as an inverted U-shaped curve: As more sugar is added, food becomes more pleasurable until we reach the bliss point at the top of the curve, and then the pleasure experience drops off.”
“Eating foods high in sugar, fat, and salt makes us eat more foods high in sugar, fat, and salt.”
Evolution, the food industry and willpower seem to have a lot to do with our food cravings and choices. Imagine if all of the grocery stores and restaurants shut down, the packaged foods and beverages disappeared and all we had left were gardens…
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