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Vol 50 - October 2008
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New Drug Approvals

The following drugs have recently been approved by the FDA.

Astepro (azelastine) Nasal Spray
Date of Approval: October 15, 2008
Treatment for: Allergic Rhinitis
Astepro Drug Information | Press Release

Cinryze (C1 Esterase Inhibitor (Human))
Date of Approval: October 10, 2008
Treatment for: Hereditary Angioedema
Cinryze Drug Information | Press Release

Rapaflo (silodosin) Capsules
Date of Approval: October 8, 2008
Treatment for: Benign Prostatic Hyperplasia
Rapaflo Drug Information | Press Release

Akten (lidocaine hydrochloride) Ophthalmic Gel
Date of Approval: October 7, 2008
Treatment for: Ocular Anesthesia
Akten 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.

Prezista (darunavir)
Patient Population Altered: October 21, 2008
Treatment for: Previously Untreated HIV-1 Infection in Adults
Prezista Drug Information | Press Release

Risperdal Consta (risperidone)
New Injection Site Approved: October 10, 2008
Treatment for: Schizophrenia
New Injection Site: Deltoid Muscle
Risperdal Consta Drug Information | Press Release

Vaprisol (conivaptan hydrochloride)
New Formulation Approved: October 8, 2008
Treatment for: Hyponatremia
New Formulation: Vaprisol Premixed in 5% Dextrose
Vaprisol Drug Information | Press Release

Seroquel XR (quetiapine)
New Indication Approved: October 8, 2008
Treatment for: Bipolar Depression and Bipolar Mania
Seroquel XR Drug Information | Press Release

Reyataz (atazanavir sulfate)
Patient Population Altered: September 30, 2008
Treatment for: Previously Untreated HIV-1 Infection in Adults
Reyataz Drug Information | Press Release

Alimta (pemetrexed)
New Indication Approved: September 26, 2008
Treatment for: First-Line Treatment of Non-Small Cell Lung Cancer
Alimta Drug Information | Press Release

Other Drug News

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

Struggling With Alcohol? Better Quit Smoking, Too
October 24, 2008
Overcoming alcoholism is tough enough. That's one reason many alcoholics who smoke continue to light up even while they're in recovery from alcohol dependency.

Cervical Cancer Vaccine Called Safe
October 22, 2008
Gardasil, the two-year-old vaccine that's designed to prevent cervical cancer, is safe say U.S. officials.

One-Quarter of Biologic Drugs Have Had Safety Issues
October 21, 2008
New research shows that almost one-quarter of biologic therapies approved in the United States and Europe since 1995 have been the subject of at least one safety-related regulatory action in the decade since they were approved.

Study Urges Low-Tech Solutions for Medical Errors
October 19, 2008
Standardizing the look of medication labels could significantly decrease costly and potentially harmful medication errors, a new study suggests.

Antibiotics May Not Cause Diarrheal Bacteria
October 10, 2008
A new study questions the commonly held belief that intestinal Clostridium difficile (C. difficile) infections are always preceded by antibiotic use.

NSAIDs Might Lower Breast Cancer Risk
October 9, 2008
Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a reduced risk for breast cancer, a new review suggests.

Drug Companies Say No Cold Meds for Kids Under 4
October 7, 2008
Saying they were acting "out of an abundance of caution," the makers of over-the-counter cough and cold medicines have said that the medicines should not be given to children younger than 4 years old.

Teens May Be Missing Out on Needed Vaccines
October 6, 2008
Although most people think of young children when they hear about childhood vaccinations, adolescents need certain booster shots as well as new immunizations.

Free Prescription Drug Samples Pose Risk to Kids
October 6, 2008
Free prescription drug samples distributed to pediatric patients may be unsafe, research suggests.

Asthma Meds Don't Work as Well in Overweight Patients
October 2, 2008
The inhaled steroids that are often used to treat asthma don't work as well in the overweight or obese, new research shows.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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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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