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A Good Night’s Rest

In a recent study of four black cohosh supplements reviewed in the Archives of Internal Medicine, only Enzymatic Therapy, Inc’s, standardized black cohosh extract treatment (Remifemin) proved beneficial in relieving menopausal vasomotor symptoms. In addition to updated information on the efficacy and safety of its product, Enzymatic has recently expanded its line of nonprescription alternative menopause therapies. A new oral tablet combines 256 mg of the sleep enhancing botanicals valerian, melissa, and hops (Remifemin Good Night) to its standardized black cohosh 40 mg treatment to relieve both menopausal symptoms including hot flashes, night sweats, irritability, and mood swings, as well as the sleeplessness that these symptoms can cause.

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Generic Approval of Panic Disorder Drug

The US Food and Drug Admin- istration (FDA) approved an application from Barr Laboratories, Inc, for the manufacturing and marketing of the generic form of Pfizer, Inc's, alprazolam extended-release tablets, 0.5 mg, 1 mg, 2 mg, and 3 mg (Xanex). Both the brand name and Barr’s new generic drug are indicated for the treatment of panic disorder with or without agoraphobia. Barr plans for immediate marketing of the drug, which will compete in a market of approximately $83 million a year according to sales data for the 12 months ending May 2006.

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Laparoscopic Adhesiolysis Liquid

After three randomized, controlled clinical trials involving 548 patients, Innovata and Baxter Healthcare Corporation announced FDA approval of their icodextrin 4% solution (Adept) indicated for intraperitoneal use for the reduction of postsurgical adhesions in patients undergoing gynecologic laparoscopic adhesiolysis. This proprietary liquid represents the first fluid-based treatment available in the United States that can be distributed directly to the treatment site though a laparoscopic delivery system. The solution represents a positive advancement for minimally invasive surgery, since laparoscopic adhesiolysis is preferred to traditional open procedures.

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Getting a Move on Colon Cleansing

The FDA has granted marketing approval for Salix Pharmaceuticals, Inc’s, pre-colonoscopy liquid bowel-cleansing agent (MoviPrep). The oral solution of PEG 3350, sodium sulfate, sodium chloride, potassium chloride, and sodium ascorbate incorporates ascorbic acid, resulting in efficacy at lower doses and better taste. The proprietary osmotic cleansing effects of the ascorbic acid allows for a much lower 2-liter dose than other cleansers which require 4 liters, while eliminating the need for concomitant administration of bisacodyl laxatives.

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