Herbal Groups advertising referred to FDA for review
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising published by Herbal Groups to the Federal Trade Commission and the Food and Drug Administration (FDA) for further review.
NAD, the advertising industry’s self-regulatory forum, had asked Herbal Groups to provide substantiation for health claims made for Prostalex Plus, which included: “Prostalex Plus has been shown in clinical studies to reduce the size of the prostate, leading to a reduced urge to urinate, improvement in urinary flow, improvement in erectile issues and increased sex drive.”
Further, NAD was concerned that “the Prostate Health Blog,” which is linked to the advertiser’s Web site and appears to be an independently written blog, is actually advertising by the company.
In response to the NAD inquiry, the advertiser submitted a study on Prostalex, but declined to participate in the NAD process. Pursuant to Section 2.9 of the NAD/NARB Procedures, NAD referred this matter to the FTC and FDA for review.
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.