Perrigo launches store-brand Prevacid 24HR
ALLEGAN, Mich. — Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength. The capsules are a generic equivalent of Novartis’ Prevacid 24HR capsules.
Sales for Prevacid OTC were approximately $220 million, Perrigo reported.
NAD: Dreambrands to moderate supplement claims following advertising review
NEW YORK — The National Advertising Division on Friday recommended Dreambrands modify or discontinue a wide range of advertising claims for “Add Lib,” a dietary supplement promoted to women for improved mood, energy and sexual desire.
Claims at issue included:
“Add Lib is an all natural supplement for women to feel better physically, mentally and emotionally — a holistic approach to sustain energy and reduce anxiety — so you can fall in love with life again.”;
“Increase your energy. Improve your mood. Regain your glow.”;
“A unique botanical blend that naturally restores energy, a healthy mood, and desire.”;
“Add Lib promotes energy, a healthy mood and sexual desire."; and
“Ignite your desire.”
Dreambrands maintained that its advertising claims were supported by published scientific literature, an independent researcher’s review of that research and the product formulation itself.
Following its review of the evidence in the record, NAD determined that the advertiser provided a reasonable basis to support claims that the ingredient, American ginseng, has been shown to enhance and improve mood. However, NAD recommended that the advertiser either discontinue the claim or modify the product or labeled dosage ensure that the product delivers a minimum of 100 mg of American ginseng per day, the amount consistent with the research shown to improve or enhance mood, promote calmness and decrease anxiety.
NAD further determined that the advertiser’s scientific evidence — including testing done on male subjects — was insufficient to support claims for improved, restored or boosted libido in females and unqualified claims of restoring, sustaining or increasing energy and recommended that these claims be discontinued.
However, NAD determined that the advertiser provided a reasonable basis for certain qualified “energy” claims provided the concept of “mental energy” is clearly explained, and directly connected to the mood benefits indicated by testing on specific ingredients in Add Lib.
“Dreambrands will modify the Add Lib formula to deliver 100 mg of American ginseng per day and will continue to use the ‘improves mood’ claims," the company replied to NAD. "We will discontinue the libido enhancement/desire claims until we can follow up with a second, more comprehensive study to more fully substantiate that Add Lib does indeed boost libido. We will also work to clearly convey the concept of ‘mental energy’ connected to mood benefits rather than the current unqualified claim."
Add Lib’s daily dosage, two capsules, delivers 120 mcg of Vitamin B12 — along with 1,310 mg of a proprietary blend containing fenugreek seed extract, American ginseng, cordyceps sinensis mycelia extract, maitake mushroom extract, wulinshen extract, passionflower herb extract, maca extract and damiana leaf extract.
NAD is an investigative unit of the advertising industry’s system of self-regulation and administered by the Council of Better Business Bureaus. As a part of its ongoing monitoring program and in conjunction with NAD’s initiative with the Council for Responsible Nutrition designed to expand review of advertising claims for dietary supplements, NAD requested the advertiser provide substantiation for claims made in print and Internet advertising and on product labeling.
McNeil Consumer recalls one lot of Imodium on wholesale level due to damaged package
FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday informed its wholesale customers that it is voluntarily recalling one lot of Imodium multi-symptom relief 18 caplets due to a packaging issue that may have impacted a limited number of blister units in this lot.
The product is being recalled at the wholesale level only, and not from consumers or from store shelves, as there are no safety concerns or adverse events related to the reason for the recall. The lot number (CMF023) for the recalled product can be found on the side of the product box.
The product is packaged on blister cards with six caplets in blister units on each card. An internal quality review discovered the potential for a limited number of blister units to have dents with a small pinhole or tear.