FDA targets marketer that claims its products treat swine flu
ROCKVILLE, Md. The Food and Drug Administration on Monday targeted ReBuilder Medical Technologies as a renegade marketer pitching its $199 “SilverCure Swine Flu Protection Pack,” that includes shampoo, lotion, conditioner and soap that supposedly deposit traces of silver according to published reports, as a product indicated for the prevention or treatment of the new H1N1 influenza virus known as the “swine flu.”
“Once included, all websites and products will remain listed,” the FDA stated. “After FDA has verified that the products or the objectionable claims related to the 2009 H1N1 Flu Virus have been removed from the web site, this information will be added to the list.”
ReBuilder Medical is attempting to capitalize on its increased web traffic with a message for browsers: “Note: Sorry, ReBuilder Medical does not sell flu products. Reporter’s mistake. Not one of the “20 sites”, but as long as you are here, please read.” In its place, ReBuilder is pitching its ReBuilder Electronic Neuromuscular Stimulator, a device that delivers small electrical shocks for pain relief.
However, a Google search for “SilverCure swine flu,” generates the URL http://www.rebuildermedical.com/outbreak/, which at one time contained the following copy: “One oz. jar of SilverCure to swab into your nose with a fresh Q-tip to coat … Because the Swine flu virus is airborne, it may settle on your hair and then ….”
That site now features the message: “This market test has voluntarily ended.”
MannKind has dip in profit, flat sales
VALENCIA, Calif. A drug company focused on developing drugs for diabetes and cancer reported a reduction in operating, research and development and general and administrative expenses of more than $32 million in its first quarter 2009 financial results Monday.
MannKind Corp. said the decrease in research and development expenses, by $15.6 million, was primarily due to decreased costs associated with the clinical development of the fast-acting insulin Afresa.
Cash, cash equivalents and marketable securities were $30.2 million as of March 31, compared with $46.5 million on Dec. 31 and $269.1 million on March 31, 2008.
“This past quarter was extremely busy for MannKind, culminating in our submission to the FDA of a new drug application for Afresa.” chairman and CEO Alfred Mann said in a statement. “With this milestone accomplished, we are now turning our attention to commercial readiness activities.”
Vagisil launches new feminine hygiene product
WHITE PLAINS, N.Y. As a brand leader in the feminine hygiene product market, Combe on Monday announced the introduction of Vagisil Satin — a fast-absorbing creme that provides quick and long-lasting relief from itch and irritation as it soothes and helps heal the skin.
“Whether at work, home or on the go, external vaginal discomfort not only causes physical stress, but also puts a damper on a woman’s mood and confidence level,” stated Adelaide Nardone, board certified OB/GYN.
According to the Journal of Urgent Care, vulvovaginitis is the cause of approximately 10 million office visits in the United States annually. Vulvovaginitis can be characterized by symptoms of itching, irritation, burning, redness, discharge and discomfort.
“These uncomfortable and sometimes painful symptoms affect women of all ages and are common gynecological concerns,” commented Jeanne Collins, Combe senior brand manager of marketing, feminine hygiene. “We are thrilled about the launch of Vagisil Satin as we continually strive to meet the needs of women by offering them a solution that immediately helps them feel more comfortable.”
Vagisil Satin contains 1% hydrocortisone acetate and provides 12 hours of relief from itch, discomfort and distraction.