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Vol 43 - March 2008
New User Reviews & Ratings
Featured News

What's new on Drugs.com

March 25, 2008
This month we've added two significant new features to the site. Firstly, we have introduced user reviews and ratings (beta). A great way to find out what others are saying about medicines you might be interested in. Simply navigate to any medicine page on Drugs.com and you'll see a yellow feedback box. Check out an example here.

Additionally, if you browse drugs by condition, you'll also notice user ratings integrated right into the condition lists. Comparing medicines has never been easier! And that's not all... we 'll soon be introducing drug and condition specific email alerts - a great way to keep up with the latest drugs being developed or to be alerted whenever a new concern is announced.

New Drug Approvals

The following drugs have recently been approved by the FDA.

Levoleucovorin for Injection
Date of Approval: March 7, 2008
Treatment for: Methotrexate Rescue; Folic Acid Antagonist Overdose
Levoleucovorin Drug Information | Press Release

Pristiq (desvenlafaxine) Extended-Release Tablets
Date of Approval: February 29, 2008
Treatment for: Depression
Pristiq Drug Information | Press Release

Arcalyst (rilonacept) Injection for Subcutaneous Use
Date of Approval: February 27, 2008
Treatment for: Cryopyrin-Associated Periodic Syndromes
Arcalyst Drug Information | Press Release

More FDA Approvals

New Indications and Dosage Forms

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

Aloxi (palonosetron hydrochloride) Injection
New Indication Approved: February 29, 2008
Treatment for: Prevention of Postoperative Nausea and Vomiting
Aloxi Drug Information | Press Release

Luvox CR (fluvoxamine maleate) Extended Release Capsules
New Dosage Form and Indication Approved: February 28, 2008
Treatment for: Social Anxiety Disorder; Obsessive Compulsive Disorder
Luvox Drug Information
| Press Release

Abilify (aripiprazole) Tablets
Patient Population Altered: February 27, 2008
Treatment for: Bipolar I Disorder in Pediatric Patients (10 to 17 years)
Abilify Drug Information | Press Release

Nexium (esomeprazole magnesium) Delayed-Release Capsules and Suspension
Patient Population Altered: February 27, 2008
Treatment for: Gastroesophageal Reflux Disease and Erosive Esophagitis in Pediatric Patients (1 to 11 years)
Nexium Drug Information | Press Release

Avastin (bevacizumab) Injection
New Indication Approved: February 22, 2008
Treatment for: Metastatic HER2-Negative Breast Cancer
Avastin Drug Information | Press Release

Humira (adalimumab) Injection
New Indication Approved: February 21, 2008
Treatment for: Juvenile Rheumatoid Arthritis
Humira Drug Information | Press Release

First Time Generic Approvals

First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.

Cefuroxime Axetil for Oral Solution
USP 125 mg/5 mL and 250 mg/5 mL
Approved: February 5, 2008 Ranbaxy Pharmaceuticals, Inc.
Generic for: Ceftin for Oral Suspension

Famotidine, Calcium Carbonate, Magnesium Hydroxide
10 mg/800 mg/165 mg Chewable Tablets
Approved: February 6, 2008 Perrigo R&D Company
Generic for: Pepcid Complete

Alendronate Sodium Tablets
USP, 5 mg (base), 10 mg (base), and 40 mg (base) for Once-Daily Dosing; and 35 mg (base) and 70 mg (base) for Once-Weekly Dosing
Approved: February 6, 2008 Teva Pharmaceuticals USA; Barr Laboratories, Inc. (70 mg Once-Weekly only)
Generic for: Fosamax Tablets

Pramipexole Dihydrochloride Tablets
0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg
Approved: February 19, 2008 Barr Laboratories, Inc.
Generic for: Mirapex Tablets

Irinotecan Hydrochloride Injection
20 mg/mL; packaged in 40 mg/2 mL and 100 mg/5 mL single-use vials
Approved: February 20, 2008 Watson Laboratories, Inc.
Generic for: Camptosar Injection

Cetirizine HCl and Pseudoephedrine HCl Extended-Release Tablets
5 mg/120 mg
Approved: February 25, 2008 Teva Pharmaceuticals USA
Generic for: Zyrtec-D Extended-Release Tablets

Calcium Acetate Capsules
667 mg (equivalent to 169 mg calcium)
Approved: February 26, 2008 Roxane Laboratories, Inc.
Generic for: Phoslo Gelcaps

Granisetron Hydrochloride Oral Solution
2 mg (base)/10 mL
Approved: February 28, 2008 Cypress Pharmaceutical, Inc.
Generic for: Kytril Oral Solution, 2 mg/10 mL

Other Drug News

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

As Problems Surface, Consumerlab.com and the People’s Pharmacy Ask FDA to Disclose Differences Between Generic and Original Drugs
March 17, 2008
An investigation by ConsumerLab.com of generic versions of the popular anti-hypertensive Toprol XL reveals that generics sold by two companies appear to differ from the original drug in how they dissolve and in their inactive ingredients. These differences may help explain complaints by consumers who have been switched to a generic version.

FDA Approval for Autoinjector
March 11, 2008
The Medical House PLC announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Group’s Compact AutoSafety Injector (CASI). This clearance permits the placing of this device in the US market for assisting the self–administered subcutaneous injection of fixed doses of FDA approved drug products which are presented in standard 1ml long pre-filled syringes with staked needles.

Congresswoman Schwartz Calls on EPA to Establish a National Taskforce to Investigate Pharmaceuticals in America’s Water Supply
March 10, 2008
In response to an Associated Press investigation that found trace quantities of pharmaceuticals in the drinking water of 41 million Americans, Congresswoman Allyson Schwartz (PA-13) today called upon the Environmental Protection Agency to establish a national taskforce to investigate this situation and make recommendations to Congress on any legislative actions needed.

Breast Cancer Risk Lingered Years after Women Discontinued Estrogen-Progestin Therapy, Stanford Researcher Says
March 4, 2008
A follow-up study of postmenopausal women who took the combination of estrogen and progestin for more than five years as part of the landmark Women's Health Initiative shows that the women continued to face an increased risk for breast cancer nearly three years after they quit taking the hormones.

New survey shows Michigan doctors embracing ePrescribing
February 27, 2008
Efforts to expand the use of ePrescribing technology received an important boost from new research released today showing ePrescribing receives high marks from constituents whose opinion about the technology may count the most – physicians. A major obstacle to widespread adoption of ePrescribing has been perception of physician resistance. But a new survey of 500 physician practices that have participated in a three-year pilot program demonstrates that a large majority of doctors and their staff who use the technology believe that it allows them to practice safer and better medicine.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

New - Compare Medications

Tools & Helpful Links

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Pill Identifier - The Pill Identifier enables a search for unidentified pills by imprint code or shape/color.

Drug Interactions Checker - Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions.

New Drugs - All the latest information on FDA Approvals and recent additions to the database.

News & Articles - Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes.

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