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Vol 52 - December 2008
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Featured News

Healthcare Costs Prevented Nearly 40 Million Americans From Filling Their Prescriptions in 2008

December 17, 2008
Nearly 40 million U.S. adults decided not to fill a prescription medication from a doctor in the past year because of the cost, according to pharmaceutical and healthcare market research company Manhattan Research's Cybercitizen Health v8.0 consumer study and strategic advisory service. The study found that women and patients with neurological and mental health conditions were the most likely to give up their medication due to cost. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Mozobil (plerixafor) Injection
Date of Approval: December 15, 2008
Treatment for: Hematopoietic Stem Cell Mobilization
Mozobil Drug Information | Press Release

Trilipix (fenofibric acid) Delayed-Release Capsules
Date of Approval: December 15, 2008
Treatment for: High Cholesterol and Hypertriglyceridemia
Trilipix Drug Information | Press Release

Lusedra (fospropofol disodium) Injection
Date of Approval: December 12, 2008
Treatment for: Monitored Anesthesia Care (MAC) Sedation
Lusedra Drug Information | Press Release

Synthetic Conjugated Estrogens-A Vaginal Cream
Date of Approval: November 28, 2008
Treatment for: Postmenopausal Symptoms
Synthetic Conjugated Estrogens-A Vaginal Cream 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.

Gleevec (imatinib mesylate) Tablets
New Indication Approved: December 19, 2008
Treatment for: Prevention of Recurrence of Gastrointestinal Stromal Tumors
Gleevec Drug Information | Press Release

Acetadote (acetylcysteine) Injection
Labeling Revision Approved: December 12, 2008
Treatment for: Acetaminophen Overdose - Lower Incidence of Side Effects
Acetadote Drug Information | Press Release

BioThrax (Anthrax Vaccine Adsorbed)
New Dosage Regimen Approved: December 11, 2008
Treatment for: Anthrax Prevention - Reduced Dosage and Intramuscular Administration
BioThrax Drug Information | Press Release

Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap))
Patient Population Altered: December 4, 2008
Treatment for: Tetanus, Diphtheria and Pertussis Prevention in Adults
Boostrix 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.

Rocuronium Bromide Injection 10 mg/mL packaged in 5 mL and 10 mL Multiple-Dose Vials
Approved: November 26, 2008 Hospira Inc.; Teva Parenteral Medicines, Inc.; Generamedix, Inc.
Generic for: Zemuron Injection

Methylergonovine Maleate Injection USP 0.2 mg/mL
Approved: November 24, 2008 Pharmaforce, Inc.
Generic for: Methergine

Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL; packaged in Unit-Dose Vials
Approved: November 18, 2008 IVAX Pharmaceuticals
Generic for: Pulmicort Respules Inhalation Suspension

Calcitonin-Salmon Nasal Spray 200 IU/Spray
Approved: November 17, 2008 Apotex, Inc.
Generic for: Miacalcin Nasal Spray

Levetiracetam Tablets 250 mg, 500 mg and 750 mg
Approved: November 3, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Keppra Tablets

Other Drug News

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

NovaDel Pharma Receives FDA Approval of Zolpimist
December 22, 2008
NovaDel Pharma Inc. has announced that Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Antisoma Receives FDA Approval for Oral Fludarabine
19 December 2008
Antisoma plc has announced that the United States Food and Drug Administration (FDA) has approved its tablet formulation of fludarabine phosphate ('oral fludarabine') as a second-line treatment for chronic lymphocytic leukemia (CLL).

New Guidelines Issued for Management of Irritable Bowel Syndrome
December 18, 2008
A leading organization of gastroenterologists has released new guidelines on the management of irritable bowel syndrome (IBS).

FDA Wants New Diabetes Drugs Tested for Heart Risks
December 17, 2008
The U.S. Food and Drug Administration is now asking all companies looking for approval of new type 2 diabetes medications to undertake studies that determine whether they cause cardiovascular problems.

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
December 16, 2008
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

FDA Faults Drug Information for Consumers
December 16, 2008
The printed consumer information that accompanies new prescription drugs is often difficult to read or understand, the U.S. Food and Drug Administration has said.

Experimental Weight-Loss Pill Passes Early Test
December 12, 2008
Researchers are hoping that an experimental new weight-loss drug will prove to be a valuable new weapon in the crusade against obesity. In recently released phase 2 trials, the drug, known as lorcaserin, resulted in substantial weight loss in obese men and women.

HRT Users Who Get Breast Cancer Less Likely to Die
December 12, 2008
Taking hormone therapy after menopause is known to increase the risk of getting breast cancer, but women who take hormone therapy and then develop breast cancer have a lower risk of dying from the disease, a new study suggests.

38% of U.S. Adults Use Alternative Treatments
December 10, 2008
An estimated 38 percent of U.S. adults and 12 percent of children use some type of complementary and alternative medicine, a new U.S. government survey finds.

Painkillers Linked to Increase in Overdose Deaths
December 9, 2008
Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests.

Electronic Prescribing Saves Patients Money
December 8, 2008
An electronic prescribing system that tells doctors which drugs are the least expensive can save millions a year, a new study finds.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

Medicare Part D

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