FDA approves new formulation of Watson’s Androderm
PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.
Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.
The drug is a testosterone replacement therapy used to treat deficiency or absence of the hormone produced by the body, a condition that affects some 13.8 million men and results from such causes as genetic abnormalities, side effects of some medications, diabetes and injury to the testes.
"The approval of the new low-dose testosterone patch offers millions of men a reliable and convenient transdermal option for what continues to be an under-diagnosed and under-treated condition," New York University School of Medicine and University Urology Associates urologist Jed Kaminetsky said on behalf of Watson. "The new Androderm formulation effectively treats symptoms of male hypogonadism, which include decreased sexual desire, fatigue and mood depression."
Pharmacy Society of Wisconsin expresses concern over WAG/ESI dispute
MANITOWOC, Wis. — A state pharmacy association here weighed in on the Walgreens and Express Scripts dispute in an editorial published online late Thursday by the Herald Times Reporter.
"We do not want to see any reputable pharmacy excluded from providing care to patients, let alone a system as large as Walgreens," wrote Thomas Engels, VP public affairs of the Pharmacy Society of Wisconsin. "However, Walgreens’ struggle with [ESI] is by no means unique. In fact, it is emblematic of the pressure being placed on pharmacies across Wisconsin," he noted. "If a large company like Walgreens can’t make the terms of Express Scripts contract work, just think how those same terms impact small pharmacies in rural parts of Wisconsin."
For the full editorial, click here.
General Mills recalls 5-count chocolate-flavored Fiber One due to labeling error
MINNEAPOLIS — General Mills on Thursday announced a voluntary recall of a single day’s production of its chocolate-flavored Fiber One 90-calorie chewy bars because of a labeling issue.
This voluntary recall includes only 5-count boxes of chocolate-flavored Fiber One 90-Calorie chewy bars with the following “better if used by” date printed on the top of the box: "19MAY2012BV."
Product produced on this date may have been packaged incorrectly, and may contain sensitive ingredients not listed on the box’s ingredient label, such as peanuts. Rather than containing chocolate-flavored Fiber One 90-calorie chewy bars, the packaging being recalled could contain chocolate peanut butter flavor Fiber One 90-calorie chewy bars.
There have been no reports of allergic reactions or illnesses associated with this product, the company reported.
No other varieties or production dates of Fiber One products are affected by this recall.