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Vol 48 - August 2008
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Featured News

More Juices Found to Affect Drugs' Effectiveness: Study

August 19, 2008
Grapefruit juice, long known to boost the absorption of certain medications, isn't the only juice that doesn't mix well with drugs, according to the Canadian researcher who first identified the ill effects of grapefruit juice.

New Drug Approvals

The following drugs have recently been approved by the FDA.

Xenazine (tetrabenazine)
Date of Approval: August 15, 2008
Treatment for: Huntington’s Chorea
Xenazine Drug Information | Press Release

Cleviprex (clevidipine butyrate)
Date of Approval: August 1, 2008
Treatment for: Hypertension
Cleviprex Drug Information | Press Release

Stavzor (valproic acid)
Date of Approval: July 29, 2008
Treatment for: Bipolar Disorder, Seizures, Epilepsy, Migraine Prophylaxis
Stavzor Drug Information | Press Release

Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione)
Date of Approval: July 24, 2008
Treatment for: Intraocular Irrigation
Navstel 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) Capsules
New Dosage Form Approved: August 22, 2008
Treatment for: Prevention of Acute Chemotherapy-induced Nausea and Vomiting
Aloxi Drug Information | Press Release

Viread (tenofovir disoproxil fumarate)
New Indication Approved: August 11, 2008
Treatment for: Chronic Hepatitis B
Viread 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.

Indomethacin for Injection
USP 1 mg/vial
Approved: July 16, 2008 Bedford Laboratories
Generic for: Indocin IV, 1 mg/vial

Doxycycline for Oral Suspension
USP, 25 mg/5 mL
Approved: July 16, 2008 IVAX Pharmaceuticals, Inc.
Generic for: Vibramycin for Oral Suspension, 25 mg/5 mL

Nisoldipine Extended Release Tablets
20 mg, 30 mg and 40 mg
Approved: July 25, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Sular Extended-Release Tablets

Mycophenolate Mofetil Capsules
250 mg
Approved: July 29, 2008 Roxane Laboratories, Inc.
Generic for: Cellcept Capsules, 250 mg

Divalproex Sodium Delayed-Release Tablets
USP, 125 mg, 250 mg and 500 mg (Valproic Acid Activity)
Approved: July 29, 2008 Dr. Reddy's Laboratories Limited; Sun Pharmaceutical Industries, Ltd.; Genpharm ULC; Upsher-Smith Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA; Lupin Limited
Generic for: Depakote Delayed-Release Tablets

Mycophenolate Mofetil Tablets
500 mg
Approved: July 29, 2008 Roxane Laboratories, Inc.
Generic for: Cellcept Tablets, 500 mg

Eplerenone Tablets
25 mg and 50 mg
Approved: July 30, 2008 Apotex, Inc.
Generic for: Inspra Tablets, 25 mg and 50 mg

Other Drug News

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

Patients Taking Cymbalta Experienced Reduced Chronic Low Back Pain in New Study
August 25, 2008
Data from a new study suggest that Cymbalta (duloxetine HCl) 60-120 mg once daily significantly reduced chronic low back pain.

Measles Cases Highest Since 1996
August 21, 2008
Some parents' refusal to vaccinate children seems to be behind the highest rate of measles cases reported since 1996, say federal officials.

New Data Show Prolonged Release Oxycodone/Naloxone Provides Effective Pain Relief and Reduces OIC in Patients with Severe Chronic Pain
August 19, 2008
Prolonged release oxycodone/naloxone is as effective as oxycodone alone in providing pain relief for patients with moderate to severe chronic pain while reducing the risk of opioid-induced constipation (OIC), according to new phase II and III data presented at the 12th World Congress on Pain.

Cholesterol Drug Plays Role in Melanoma Remission
August 12, 2008
A drug widely used to treat high cholesterol is helping beat cancer. Lovastatin is part of a new cancer treatment that has arrested or eradicated tumors in more than 80% of initial patients.

Proton Pump Inhibitors Increase Risk of Bone Fractures
August 11, 2008
Patients who use proton pump inhibitors for 7 or more years to treat reflux, peptic ulcers and other conditions are at greater risk of osteoporosis-related fractures, according to this large observational study of 15,792 patients published in CMAJ.

Cannabis-Linked Cell Receptor Might Help Prevent Colon Cancer
August 1, 2008
A cannabinoid receptor lying on the surface of cells may help suppress colorectal cancer, say U.S. researchers. When the receptor is turned off, tumor growth is switched on. Cannabinoids are compounds related to the tetrahydrocannabinol (THC) found in the cannabis plant.

Exercise in a Pill
July 31, 2008
Trying to reap the health benefits of exercise? Forget treadmills and spin classes, researchers at the Salk Institute for Biological Studies may have found a way around the sweat and pain.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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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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