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Aminolevulinic Acid News

FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas

Posted 22 Jun 2017 by Drugs.com

June 6, 2017 - The U.S. Food and Drug Administration (FDA) has approved Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. The approved recommended reconstituted oral dose of Gleolan is 20 mg/kg administered 3 hours (range 2 to 4 hours) prior to induction of anesthesia. During neurosurgery, Gleolan is used with an operating microscope adapted with a blue emitting light source and filters for excitation light of wavelength 375 to 440 nm, and observation at wavelengths of 620 to 710 nm. Due to the risk of phototoxic reactions, do not administer phototoxic drugs for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 24 hours ... Read more

Related support groups: Surgery, Brain Tumor, Diagnosis and Investigation, Aminolevulinic Acid, Gleolan

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

Posted 8 Jun 2016 by Drugs.com

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 Drugs.com

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, Therapeutic, Mupirocin, Bactroban, Efudex, Lidoderm, Maintain, Drysol, Sulfur, Basal Cell Carcinoma, Hypercare, Epiduo

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