FDA advisory committee to consider OTC NDA for asthma-relieving Primatene HFA
SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers 12 years of age and older.
The epinephrine inhaler was developed as a replacement for Primatene Mist (epinephrine metered inhaler 200 mcg/actuation), an OTC product that was phased out in December 2011 because of the use of chlorofluorocarbons as the propellant.
The committee will be asked to consider whether the data support an acceptable risk/benefit profile of the epinephrine inhaler for use by OTC consumers.
The following day, the committee will meet to discuss whether OTC bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing) should be removed from the monograph altogether. Specific drugs to be discussed include epinephrine, epinephrine bitartrate and racepinephrine hydrochloride.
GSK Consumer Healthcare launches ’60-Day Kickstart’ campaign for weight loss
PARSIPPANY, N.J. — GlaxoSmithKline is offering a new online campaign under the Alli brand to support healthy weight-loss resolutions, the company said Thursday.
GSK Consumer Healthcare announced the launch of the 60-Day Kickstart campaign that offers free support for starting a healthy, balanced diet for the new year. Benefits offered include two months of free, motivational tips and reminders; accessibility and encouragement from New York-registered dietician Betty Kovacs; exclusive, balanced gourmet recipes that align with the Alli diet plan; and an open community and social forum for support.
"For many, New Year’s is all about starting over and being smarter about your diet, Alli brand marketing director Deborah Larsen said. "As part of the program, the Alli brand has teamed up with celebrity chef, restauranteur and author Richard Blais for exclusive, easy, healthy recipes and New York-registered dietician Betty Kovacs, who will be making regular appearances online and offering her expert advice."
Calorease sets itself apart with active ingredient FBCx
TORONTO — Soho Flordis is in the process of launching Calorease, a dietary supplement that helps bind to the fat in foods and reduce caloric intake up to 500 calories a day. One of the differentiators setting this diet aid apart from other supplements is the active ingredient — FBCx (α-cyclodextrin), a stimulant-free, heart-healthy fiber. FBCx binds up to nine times its weight in fat from food, safely removing it from the body before it can be absorbed.