NEWS UPDATE
 Volume 36 - June 2007

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Top News Headlines
The latest Pharmaceutical News & Articles brought to you by Drugs.com.

FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
PARIS, June 13, 2007 - Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of rimonabant (Zimulti / Accomplia) to the US FDA...

Gabapentin Shown Effective for Fibromyalgia Pain
BETHESDA, Md., June 11, 2007 - New research supported by the National Institutes of Healths National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) shows that the anticonvulsant medication gabapentin, which is used for certain types of seizures, can be an effective treatment for the pain and other symptoms associated with the common, often hard-to-treat chronic pain disorder, fibromyalgia...

Pediatric Inhaled Corticosteroid Asthma Medication Features New Dose Counters to Help Track Usage
Dose Counters May Help Reduce Potential for Patients Inadvertently Running out of Medication.
RESEARCH TRIANGLE PARK, N.C., June 11, 2007 - GlaxoSmithKline announced today the nationwide availability of two formulations of an inhaled corticosteroid (ICS) with a dose counter -- Flovent(R) HFA 44 mcg (fluticasone propionate 44 mcg inhalation aerosol) and Flovent(R) Diskus(R) 50 mcg (fluticasone propionate inhalation powder) -- for children ages four and older with mild, persistent asthma...

Roche Recalls Viracept Due to Chemical Impurity
Patients are requested to contact their doctors to discuss alternative therapies.
BASEL, Switzerland, 06. June 2007Roche, in  agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall....

Takeda Revises Actos (pioglitazone HCl) Prescribing Label
DEERFIELD, Ill., June 06, 2007 - Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the company will revise warnings related to congestive heart failure (CHF) in the prescribing label of its type 2 diabetes medication ACTOS(R) (pioglitazone HCl)...

American Diabetes Association Strongly Advises Patients Using Rosiglitazone to See Their Doctor
ALEXANDRIA, Va., June 06, 2007 - On June 5, 2007, the New England Journal of Medicine published results of an interim analysis of the cardiovascular safety trial of rosiglitazone (brand name, Avandia). The article was accompanied by three editorials. Although the findings from RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of...

Copaxone Pre-Filled Syringe Can Now Be Stored for up to One Month at Room Temperature
JERUSALEM & PARIS, Jun 6, 2007 - Teva Pharmaceutical Industries, Ltd. and sanofi-aventis today announced that the application for up to one month room temperature storage of Copaxone (glatiramer acetate injection) pre-filled syringe has been approved by the U.S. Food and Drug Administration (FDA) and in Europe under the Mutual...

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Did You Know...
This month we are highlighting a few of the lesser know interactive features available to members of Drugs.com

1. Phonetic Search
Not sure how to spell a drug name? Type the drug name the way it sounds in our new phonetic search.

2. Save a Drug List
Want to keep a list of drugs for future reference? Wherever you see the  icon on a drug information page, simply click it and that drug will be added to your list (you must be signed in). Use the searchbox at the top of the page to search for drugs to add to your list. Look for the link "Add to my drug list" in search results pages and information pages. You can even add drugs to your list directly from your Viewing History. Once this is done, you have a list for future reference, plus you can select drugs from your list to check for interactions.

 

Latest Drug Approvals
The following drugs have recently been approved by the FDA.

Divigel (estradiol) Gel
Date of Approval: June 4, 2007
Treatment for: Menopausal Symptoms

Torisel (temsirolimus) Injection
Date of Approval: May 30, 2007
Treatment for: Advanced Renal Cell Carcinoma

Xyzal (levocetirizine dihydrochloride) Tablets
Date of Approval: May 25, 2007
Treatment for: Allergy Symptoms

Lybrel (levonorgestrel and ethinyl estradiol) Low Dose Continuous Regimen
Date of Approval: May 22, 2007
Treatment for: Contraception

Perforomist (formoterol fumarate) Inhalation Solution
Date of Approval: May 11, 2007
Treatment for: Chronic Obstructive Pulmonary Disease

Neupro (rotigotine) Transdermal System
Date of Approval: May 9, 2007
Treatment for: Parkinson's Disease

Supprelin-LA (histrelin acetate) Subcutaneous Implant
Date of Approval: May 3, 2007
Treatment for: Central Precocious Puberty

AzaSite (azithromycin) Ophthalmic Solution
Date of Approval: April 27, 2007
Treatment for: Bacterial Conjunctivitis

Veramyst (fluticasone furoate) Nasal Spray
Date of Approval: April 27, 2007
Treatment for: Allergy Symptoms

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Latest FDA MedWatch Alerts
MedWatch alerts are concerning pharmaceuticals already released in the USA and are issued by the FDA.

Toothpaste Imported From China May Contain Diethylene Glycol
June 1, 2007 - Audience: Consumers, healthcare professionals
FDA warned consumers to avoid using tubes of toothpaste labeled as "Made in China". The warning and an import alert were issued to prevent toothpaste containing a poisonous chemical...

Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron
May 29, 2007 - Audience: Consumers, healthcare professionals
Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant...

Guaifenesin (Unapproved) Timed-Release Drug Products
May 25, 2007 - Audience: Consumers, healthcare professionals
FDA informed consumers and healthcare professionals of its intent to take action against companies that market unapproved timed-release dosage form of guaifenesin products, a...

Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance
May 23, 2007 - Audience: Radiologists, Nephrologists, Dermatologists, other healthcare professionals
FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of...

Exjade (deferasorix) Tablets For Oral Suspension
May 22, 2007 - Audience: Oncologists, Hematology-Oncologists, Pediatric Hematologists, Specialty Pharmacists
Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling...

Exjade (deferasirox) Tablets For Oral Suspension
May 22, 2007 - Audience: Oncologists, Hematology-Oncologists, Pediatric Hematologists, Specialty Pharmacists
Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling...

Caffeine Citrated, Powder, Purified
May 21, 2007 - Audience: Hospital risk managers, pediatricians, pharmacists, other healthcare professionals
Spectrum and FDA informed healthcare professionals of a nationwide recall of 3 lots (TS0225, UK0821, and V11203) of Caffeine Citrated,...

Avandia (rosiglitazone)
May 21, 2007 - Audience: Endocrinologists, other healthcare professionals, consumers
FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of...

NBTY Shark Cartilage Capsules
May 17, 2007 - Audience: Consumers, healthcare professionals
NBTY and FDA informed consumers and healthcare professionals of a nationwide recall of 3 lots of Shark Cartilage Capsules the company manufactured in 2004 and distributed to consumers...

Energy Max
May 10, 2007 - Audience: Consumers, healthcare professionals
FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary...

OxyContin, Illegal Promotion by Manufacturer
May 10, 2007 - Audience: Pain management specialists, healthcare professionals, consumers
FDA informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal...

True Man
May 10, 2007 - Audience: Consumers, healthcare professionals
FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary...

Glycerin compounded products
May 7, 2007 - Audience: Pharmaceutical manufacturers, suppliers, drug repackers, compounding healthcare professionals
FDA warned pharmaceutical manufacturers, suppliers, drug repackers, and healthcare professionals who compound medications...

Antidepressant Medication Products
May 2, 2007 - Audience: Healthcare professionals, consumers
FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for...

PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products
April 25, 2007 - Audience: Consumers, healthcare providers
FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and...

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