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Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis

Posted 8 Jun 2016 by

Leverkusen, Germany, May 11, 2016 – Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz (BF-200 ALA) and medical device BF-RhodoLED® for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. The approval covers lesion-directed as well as field-directed treatment and follows thorough review of the Company’s New Drug Application (NDA), which was submitted in July 2015. This marks an outstanding accomplishment for a start-up company that is rarely seen in European companies of comparable size. It is the fourth marketing approval of Ameluz worldwide and further validates the comprehensive safety and efficacy data from the Company’s three pivotal multi-center clinical trial ... Read more

Related support groups: Skin Cancer, Actinic Keratosis, Ameluz, Aminolevulinic Acid

Retail Prices of Dermatology Drugs Skyrocket

Posted 25 Nov 2015 by

WEDNESDAY, Nov. 25, 2015 – Patients using prescription creams, gels, sprays and pills for skin conditions may shell out substantially more at the pharmacy than they did just six years ago, a new study suggests. Between 2009 and 2015, retail prices of brand-name dermatologic drugs rose 401 percent, on average, study authors reported Nov. 25 in JAMA Dermatology. Even generics have succumbed to price inflation, up 279 percent between 2011 and 2014, based on the drugs surveyed. Price increases for skin treatments far outpaced the general inflation rate of 11 percent during the six-year study period, the researchers said. "Cancer drugs were the worst in terms of the numbers" – up 1,240 percent or nearly $11,000 over the six-year study period – primarily because of two medicines, said Dr. Steven Rosenberg, voluntary professor of dermatology at the University of Miami Miller School of ... Read more

Related support groups: Monistat, RID, Monistat 3, Eczema, Monistat 7, Voltaren Gel, Dermatitis, Clobetasol, Contact Dermatitis, Mupirocin, Epiduo, Sulfur, Drysol, Efudex, Therapeutic, Basal Cell Carcinoma, Maintain, Bactroban, Silver, Retin-A

FDA Medwatch Alert: Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes

Posted 21 Aug 2015 by

ISSUE: FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. See the FDA Drug Safety Communication for additional information and recommendations. Patients should use Picato gel as prescribed by their health care professionals, and should not use it on an area of skin larger or for a longer period than instructed in the drug label. Also patients should avoid applying the gel in, near, ... Read more

Related support groups: Actinic Keratosis, Picato, Keratosis, Ingenol Mebutate

Light Therapy a Good Option for Pre-Cancerous Skin Lesions, Study Says

Posted 27 Aug 2014 by

WEDNESDAY, Aug. 27, 2014 – Treating pre-cancerous skin spots with a type of light therapy may be more effective than the usual therapy – freezing the lesions with liquid nitrogen, a new study suggests. Rough, scaly spots, called actinic keratoses, are often found on the scalp and face of people with fair complexions who've had a lot of sun exposure. This review of prior research found that people who underwent the light treatment – called photodynamic therapy – were 14 percent more likely to have the lesion completely cleared three months later than those who had the freezing treatment known as cryotherapy. Photodynamic therapy "is associated with better outcomes," said Dr. Daniel Eisen, the study's lead author. "It's a relatively new treatment. Freezing has been done for decades." Eisen, director of aesthetic dermatology at the University of California, Davis Health System, said ... Read more

Related support groups: Actinic Keratosis

New Gel Treats Precancerous Skin Condition in Days: Study

Posted 14 Mar 2012 by

WEDNESDAY, March 14 – A newly approved gel appears effective in treating a condition called actinic keratosis, which is a common precursor to squamous cell skin cancer, a new study finds. Earlier topical treatments took weeks or even months to treat the condition, but the new product – Picato (ingenol mebutate) gel – can work in a matter of days, according to the report in the March 15 issue of the New England Journal of Medicine. "There are a number of agents available to treat precancerous skin lesions," said study author Dr. Mark Lebwohl, a professor and chairman of dermatology at Mount Sinai School of Medicine in New York City. "Most of the other ones are applied over a period of weeks to months and have a reaction that lasts for a long time, so it interferes with your life for a good period of time. This one is unique in that it is applied for only one to three days," he said. ... Read more

Related support groups: Actinic Keratosis, Picato, Squamous Cell Carcinoma

FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing

Posted 25 Jan 2012 by

PARSIPPANY, N.J., January 25, 2012, 2012 /PRNewswire/ – Leo Pharma announced today that the U.S. Food and Drug Administration (FDA) approved Picato (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). AK is a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma (SCC), the second most common type of skin cancer.[1],[2] Picato 0.015% gel is used once daily on the face and scalp for three consecutive days, and Picato 0.05% gel is used once daily on the trunk and extremities for two consecutive days.[3] Picato gel is the first and only topical AK therapy that can be used for as little as two or three days. According to the American Academy of Dermatology (AAD), 1 in 5 Americans will develop skin cancer in the course of their lifetime.[4] Studies show that about 65 percent of squamous ... Read more

Related support groups: Actinic Keratosis

FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses

Posted 29 Jul 2011 by

BRISTOL, Tenn.--(BUSINESS WIRE)--Jul 18, 2011 - Graceway Pharmaceuticals, LLC (Graceway) announced today that the Food and Drug Administration (FDA) has approved Zyclara Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new formulation may be used on the full face or balding scalp in a convenient 6-week dosing cycle. "The addition of a 2.5% formulation of Zyclara Cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses," said Dr. Darrell S. Rigel, a clinical professor of dermatology at New York University Medical Center and a former president of the American Academy of Dermatology. "The lower concentration offers greater tolerability while maintaining the efficacy that has long ... Read more

Related support groups: Imiquimod, Actinic Keratosis, Zyclara

FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses

Posted 29 Mar 2010 by

BRISTOL, Tenn., March 26 /PRNewswire/ – Graceway Pharmaceuticals announced today that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zyclara, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle. Zyclara shares the same active ingredient as Aldara (imiquimod) Cream, 5% and while both topicals are FDA-approved for the treatment of AK, there are notable differences between the two. Zyclara is indicated for daily use on an accelerated 6-week dosing cycle comprised of two weeks of daily treatment with Zyclara, two weeks of non-treatment, followed by two weeks of daily treatment with Zyclara. Aldara is not approved for daily use and its approved ... Read more

Related support groups: Imiquimod, Actinic Keratosis

Chemo Drug May Help Sun-Damaged Skin

Posted 15 Jun 2009 by

MONDAY, June 15 – Applying the chemotherapy drug fluorouracil to skin might help improve the appearance of sun-damaged areas and reduce potentially precancerous patches, according to a small, new study. Fluorouracil is used to treat cancers of the colon, head and neck, pancreas and other organs. Changes in skin appearance have been noted in people undergoing treatment with systemic fluorouracil, and this led to the development of a skin cream that contains the cancer drug. The new study included 21 healthy volunteers with sun-damaged skin and actinic keratoses – skin lesions that could develop into skin cancer – on their faces. The participants applied 5 percent fluorouracil cream to their faces twice daily for two weeks. The researchers said that the number of actinic keratoses declined from an average of 11.6 lesions per person to an average of 1.5 lesions. There were also ... Read more

Related support groups: Carac, Actinic Keratosis

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Efudex, Carac, Picato, Fluoroplex, Tolak, Ameluz, ingenol mebutate, diclofenac / fluorouracil, Efudex Occlusion Pack, Fluorac