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Help My Hurt

Archive for the ‘FDA Announcements’ Category

July 1st, 2008

Press release: FDA Approves Aciphex for Short-Term Treatment of GERD in Teens

FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ — Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved Aciphex (rabeprazole sodium) 20 mg for […]

By Marijke Durning, RN -- 0 comments

June 16th, 2008

Press Release: FDA Approves Cymbalta for Management of Fibromyalgia

Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients
INDIANAPOLIS, June 16 /PRNewswire-FirstCall/ — The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced today. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing […]

By Marijke Durning, RN -- 1 comment

June 10th, 2008

FDA Recall: Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot

 
PRESS RELEASE:
Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness
ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a […]

By Marijke Durning, RN -- 2 comments

June 10th, 2008

Press Release: FDA Broadens Indication for Once-Yearly Reclast for Prevention of Fractures After a Hip Fracture

FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
- Revised label includes data showing 35% reduction in new clinical fractures in patients treated with Reclast following a recent hip […]

By Marijke Durning, RN -- 0 comments

June 4th, 2008

FDA reviewing some arthritis drugs

Some of the most useful medications for arthritis treatment are now undergoing a review, according to an FDA announcement. These medications, Enbrel, Humira (Press release: FDA Approves HUMIRA (adalimumab) for Juvenile Arthritis), Remicade, and Cimzia are also used for the treatment of Crohn’s disease because of their effect on reducing inflammation. The drugs are very […]

By Marijke Durning, RN -- 2 comments

May 1st, 2008

FDA Approves Amitiza for IBS-C

FDA Press Release

FDA Approves Amitiza for IBS-C
Only drug available in United States for irritable bowel syndrome with constipation

This release contains revisions posted April 30, 2008
The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no […]

By Marijke Durning, RN -- 0 comments

April 26th, 2008

New medication for opioid-induced constipation

If you’re living with chronic pain and have to take heavy duty pain medications to be able to function, the last thing you should have to worry about is constipation. Unfortunately though, the opioid, or narcotic, class of drugs is famous for causing constipation.
According to the article FDA Approves Relistor For Opioid-Induced Constipation, Relistor acts […]

By Marijke Durning, RN -- 2 comments

April 25th, 2008

Once monthly dose of Actonel approved for postmenopausal osteoporosis

Great news for women who take Actonel for postmenopausal osteoporosis: the FDA approved a new once-a-month dose of Actonel.
Here is the press release:
CINCINNATI and BRIDGEWATER, N.J., April 24 /PRNewswire-FirstCall/ — The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel(R) (risedronate sodium) tablets for the treatment and prevention of […]

By Marijke Durning, RN -- 0 comments

April 23rd, 2008

FDA approves drug for people living with pain from Crohn’s disease

People who live with chronic pain from Crohn’s disease are not given much hope in terms of treatment. Yesterday, however, the FDA approved a new drug for the treatment of moderate-to-severe Crohn’s disease:
Press Release:
FDA Approves Cimzia to Treat Crohn’s Disease
A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and […]

By Marijke Durning, RN -- 0 comments

March 29th, 2008

FDA warning: “Total Body Formula” and “Total Body Mega Formula”

PRESS RELEASE

FDA Warns Consumers about “Total Body Formula” and “Total Body Mega Formula”
Distributor recalls dietary supplement products after reports of adverse reactions

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine […]

By Marijke Durning, RN -- 0 comments

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