FDA approves Mylan migraine drug
PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.
Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.
The drug is a generic version of IPR Pharmaceuticals’ Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.
Ouidad introduces new Color Sense collection
NEW YORK — Just in time for summer, Ouidad is set to launch its new line of Color Sense products designed to preserve and protect hair color from fading caused by sun exposure and other environmental factors that can damage hair.
The Color Sense trio included a shampoo and conditioner with a proprietary Color Lock complex, as well as the Shine Booster Color Extender treatment, which nourishes, shields, enhances vibrancy and extends the life of color, according to the company.
The Color Sense Collection gently removes mineral deposits and product build-up that can lead to premature stripping of color. In addition, each product has a variety of benefits for hair.
- Color Preserving Shampoo: Gently removes mineral deposits and product buildup that can strip color ; provides a shield against fading from UV exposure and styling ; hair is instantly hydrated, healthy and vibrant; sulfate free.
- Color Preserving Conditioner: Protective Color Lock complex affixes color to hair fibers and provides a shield against fading from UV exposure and styling; nourishes and replenishes hydration to help keep hair healthy looking and soft; sulfate free and silicone free.
- Shine Boosting Color Extender: Instantly creates a high gloss finish that lasts for days; extends life of hair color; protects from UV and styling damage; sulfate-free and silicone free.
The Color Preserving Shampoo comes with a suggested retail price of $20 for an 8.5 fl. oz. bottle. The Color Preserving Conditioner comes with a SRP of $22 for 8.5 fl. oz. The Shine Boosting Color Extender has a SRP of $26 for a 5 fl. oz. bottle.
The Ouidad Color Sense Collection is available at Ouidad.com, Ouidad Flagship, certified salons and Ulta.
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FDA approves new prostate cancer drug
SILVER SPRING, Md. — A new treatment for late-stage prostate cancer has received approval from the Food and Drug Administration.
The FDA announced Wednesday the approval of Bayer’s Xofigo (radian Ra 223 dichloride) for men with symptomatic, castration-resistant prostate cancer that has spread to the bones but not other organs, also known as metastasis. The drug is designed for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer."
Pazdur was referring to Astellas’ and Medivation’s Xtandi (enzalutamide), which the agency approved in August 2012 for men with metastatic, castration-resistant prostate cancer that has spread and recurred after medical or surgical therapy after they have been treated with the chemotherapy drug docetaxel.