B&L shareholders vote for merger
ROCHESTER, N.Y. Bausch & Lomb on Friday announced that its shareholders voted to approve the proposed merger with affiliates of Warburg Pincus at a special meeting of shareholders held earlier this morning.
“We are pleased with the outcome of today’s vote,” stated Ronald Zarrella, chairman and chief executive officer of Bausch & Lomb. “On behalf of the Bausch & Lomb Board and management team, I want to thank our shareholders, customers and dedicated employees for their support throughout this process. We look forward to promptly completing the transaction.”
The tabulation indicates that more than two thirds of the total shares outstanding and entitled to vote at the meeting were voted in favor of the transaction.
In accordance with the terms of the merger agreement, at the closing, each outstanding share of common and Class B stock of Bausch & Lomb will be cancelled and converted into the right to receive $65 in cash, without interest, less any applicable withholding taxes. The transaction, which is subject to customary closing conditions, is expected to close early in the third quarter. Pursuant to the merger agreement, affiliates of Warburg Pincus are not required to consummate the merger until after expiration of a “marketing period” of 20 business days following the shareholder vote. Closing of the merger is not subject to a financing condition.
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P&G gets warning letter from FDA regarding hand sanitizer
Procter & Gamble Co. may need to wash its hands clean of a new sanitizerthat health officials say is hazardous to children.
The Food and Drug Administration on Tuesday released a warning letter it had sent to P&G for “making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer product,” the agency stated.
The agency reported that the product’s claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act, citing specifically P&G promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours. Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims.
“FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,” stated Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “Over-the-counter drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”
Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugs’ labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed.
There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. In this case, the product’s claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph, the agency stated. Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes claims regarding the prevention of colds.
P&G spokesman David Bernens said on Tuesday that the company would comply with the FDA’s complaints.
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NAD chastises Natrol for claims about Promensil
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday recommended that Natrol, which distributes Promensil, a dietary supplement marketed for the relief of the symptoms of menopause, modify or discontinue certain claims for the supplement. NAD did find, however, that the advertiser had provided adequate support for certain claims.
At the outset of the NAD inquiry, Natrol explained that Promensil is a brand of dietary supplement for the relief of menopausal symptoms. The supplement contains an extract of red clover, standardized to provide four naturally occurring isoflavones, biochanin A, formononetin, genistein and daidzein.
Following a review of each of the 22 cited studies, NAD found that while there is significant research that Promensil may provide certain benefits for menopausal women, the challenged advertising overstates the results of such research.
Specifically, NAD determined that there was insufficient evidence to support the message conveyed by the advertiser’s claim that “22 clinical studies can’t be wrong.” NAD determined, as well, that because of conflicting efficacy research, as well as deficiencies in many of the studies, the evidence was not sufficiently reliable to support the advertiser’s unqualified “clinically proven” claims and recommended that such claims be discontinued or modified.
NAD further recommended that the advertiser’s “Doctor Recommended” claim be modified to clearly and conspicuously disclose that the doctors surveyed were Australian and Canadian.
With respect to claims concerning hot flashes, NAD found that, based on the current research, the advertiser can make qualified claims that more accurately reflect the current state of the science, i.e., that Promensil may help reduce the frequency and/or the severity of hot flashes.
NAD also found that Natrol provided a reasonable basis to make certain limited claims that Promensil can help relieve the frequency and/or severity of hot flashes, increase testosterone which may alleviate certain mood swings, promote breast health, promote heart health and promote emotional well-being.
Natrol noted in its advertiser’s statement that it would modify its advertising to conform to NAD’s findings, the NAD reported. “Natrol thanks the NAD for its consideration and review of the evidence submitted to it by Natrol. Although Natrol respectfully disagrees with the decision reached by the NAD, it voluntarily accepts the NAD’s recommendations and suggestions on the claims in question,” the company stated in its letter to NAD.
Thank you, NAD, for this (2007) report on Promensil. I have just purchased this product on the recommendation of my pharmacist. Obviously, the company took your recommendations to heart and re-worded it's claims. However, I must say, in my case, that is, that the product seems to be living up to its promises/statements. I have been suffering from severe menopausal symptoms for the last six years; it's been horrible living like I have been. But, since starting the Promensil six days ago I have noticed a significant decrease in the number of hot flashes I usually have throughout the day. The severity (thank you, Jesus) of the heat and sweating is GREATLY reduced. :) So, I want to thank you for looking out for consumers and your fair reporting, and a big thank you to Natrol for putting out this great product!