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Vol 47 - July 2008
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Featured News

New Study Shows Drug Combats Previously Untreatable Prostate Cancers

July 21, 2008
New, groundbreaking research reveals the drug abiraterone could treat up to 80 percent of patients with aggressive and previously drug resistant prostate cancer, according to a study published in the Journal of Clinical Oncology.

New Drug Approvals

The following drugs have recently been approved by the FDA.

Eovist (gadoxetate disodium)
Date of Approval: July 3, 2008
Treatment for: Liver Magnetic Resonance Imaging
Eovist Drug Information | Press Release

Evolence (dermal filler)
Date of Approval: June 27, 2008
Treatment for: Facial Wrinkles
Evolence Drug Information | Press Release

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
Date of Approval: June 24, 2008
Treatment for: Prophylaxis of Diphtheria, Tetanus, Pertussis and Poliomyelitis
Kinrix 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.

Aciphex (rabeprazole sodium) Delayed Release Tablets
Patient Population Altered: June 30, 2008
Treatment for: GERD in Adolescents
Aciphex Drug Information | Press Release

Concerta (methylphenidate HCl) Extended-Release Tablets
Patient Population Altered: June 27, 2008
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD) in Adults
Concerta 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.

Zaleplon Capsules
5 mg and 10 mg
Approved: June 6, 2008 Sandoz Inc.; Genpharm ULC; Unichem Laboratories Limited; Aurobindo Pharma Limited; Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA; Roxane Laboratories, Inc.
Generic for: Sonata Capsules

Prednisolone Sodium Phosphate Oral Solution
20 mg (base)/5 mL (new strength)
Approved: June 9, 2008 Pharmaceutical Associates, Inc.
Generic for: Orapred Oral Solution

Ciclopirox Gel
Approved: June 10, 2008 Nycomed US, Inc.
Generic for: Loprox Gel

Torsemide Injection
10 mg/mL; 2 mL and 5 mL vials
Approved: June 10, 2008 Bedford Laboratories
Generic for: Demadex Injection, 10 mg/mL

Dronabinol Capsules
USP, 2.5 mg, 5 mg, and 10 mg
Approved: June 27, 2008 Par Pharmaceutical, Inc.
Generic for: Marinol Capsules, 2.5 mg, 5 mg, 10 mg

Risperidone Tablets
USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
Approved: June 30, 2008 Teva Pharmaceuticals USA
Generic for: Risperdal Tablets

Other Drug News

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

Family Meals Can Help Teen Girls Avoid Drugs, Alcohol
July 23, 2008
Eating meals together as a family can reduce a teen girl's risk of turning to alcohol or drugs, a new study suggests.

NEJM Publishes Nexavar Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
July 23, 2008
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that The New England Journal of Medicine published results of a Phase 3 trial demonstrating that Nexavar (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo.

New Study Shows Drug Combats Previously Untreatable Prostate Cancers
July 21, 2008
New, groundbreaking research reveals the drug abiraterone could treat up to 80 percent of patients with aggressive and previously drug resistant prostate cancer, according to a study published in the Journal of Clinical Oncology.

Epilepsy Drug May Increase Risk of Birth Defects
July 21, 2008
Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology, the medical journal of the American Academy of Neurology.

New Report: Investment in Disease Prevention Could Save America More than $16 Billion in Five Years
July 17, 2008
A small strategic investment in disease prevention could result in significant savings in U.S. health care costs, according to a new report released today by the Trust for America's Health (TFAH). In its report, entitled Prevention for a Healthier America: Investments in Disease Prevention Yield Significant Savings, Stronger Communities, TFAH finds that an investment of $10 per person per year in proven community-based programs to increase physical activity, improve nutrition, and prevent smoking and other tobacco use could save the country more than $16 billion annually within five years.

Eight-Year Melanoma Remission is Among Early Cancer Treatment Results
July 14, 2008
A newly available treatment already has benefited several individuals with aggressive malignancies. Offered through NeoPlas Innovation, this regimen has arrested or eradicated tumors in more than 80% of initial patients.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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