Vol 42 - Feb 2008

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Latest FDA New Drug Approvals
The following drugs have recently been approved by the FDA.

Xyntha (antihemophilic factor (recombinant), plasma/albumin free)
Date of Approval: February 21, 2008
Treatment for: Hemophilia A
Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.
Xyntha Drug Information | Press Release

Simcor (niacin ER and simvastatin) Tablets
Date of Approval: February 15, 2008
Treatment for: Hyperlipidemia
Simcor (Niaspan/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.
Simcor Drug Information | Press Release

Moxatag (amoxicillin) Extended Release Tablets
Date of Approval: January 23, 2008
Treatment for: Tonsillitis/Pharyngitis
Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).
Moxatag Drug Information | Press Release

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets
Date of Approval: January 18, 2008
Treatment for: Hypertension
Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.
Tekturna HCT Drug Information | Press Release

Intelence (etravirine) Tablets
Date of Approval: January 18, 2008
Treatment for: HIV Infection
Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
Intelence Press Release | Press Release

Flo-Pred (prednisolone acetate) Oral Suspension
Date of Approval: January 17, 2008
Treatment for: Asthma and Inflammatory Conditions
Flo-Pred (prednisolone acetate) is a cherry flavored oral liquid corticosteroid formulation which does not require refrigeration and does not require shaking prior to use. Flo-Pred is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.
Flo-Pred 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.

Asmanex Twisthaler (mometasone furoate) Inhalation Powder
Patient Population Altered: February 4, 2008
Treatment for: Asthma
Asmanex is an inhaled corticosteroid indicated for the first-line maintenance treatment of asthma as preventive therapy. Asmanex Twisthaler was first approved in 2005 for patients 12 years of age and older, and is now also approved for use in patients 4 to 11 years of age.
Asmanex Twisthaler Drug Information | Press Release

Xyzal (levocetirizine dihydrochloride) Oral Solution
New Dosage Form Approved: January 28, 2008
Treatment for: Allergy Symptoms
Xyzal is an antihistamine for the relief of allergy symptoms. Xyzal was first approved in 2007 as tablets and is now also available as an oral solution formulation.
Xyzal Drug Information | Press Release

Emend (fosaprepitant dimeglumine) for Injection
New Dosage Form Approved: January 25, 2008
Treatment for: Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
Emend (fosaprepitant dimeglumine) is a substance P/neurokinin 1 (NK-1) receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV). Emend for Injection is an intravenous prodrug of the oral formulation of Emend which provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. Emend oral capsules were approved for the same indication in 2003.
Emend Drug Information | Press Release

Mycamine (micafungin sodium) Injection
New Indication Approved: January 22, 2008
Treatment for: Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
Mycamine is an echinocandin antifungal agent first approved in 2005 for the treatment of esophageal candidiasis and for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Mycamine is now also approved for the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses.
Mycamine Drug Information | Press Release

Humira (adalimumab) Injection
New Indication Approved: January 18, 2008
Treatment for: Psoriasis
Humira is a tumor necrosis factor (TNF) blocker first approved in 2002 for the treatment of rheumatoid arthritis. Humira has since been approved for the treatment of psoriatic arthritis, ankylosing spondylitis, Crohn's disease and is now also approved for the treatment of patients with moderate to severe chronic plaque psoriasis.
Humira Drug Information | Press Release

Welchol (colesevelam) Tablets
New Indication Approved: January 18, 2008
Treatment for: Type 2 Diabetes
Welchol is a bile acid sequestrant first approved in 2000 to reduce elevated low-density lipoprotein cholesterol levels in patients with primary hyperlipidemia. Welchol is now also approved to improve glycemic control in adults with type 2 diabetes mellitus.
Welchol 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.

Cetirizine Hydrochloride Chewable Tablets 5 mg and 10 mg
Approved: January 11, 2008 Caraco Pharmaceutical Laboratories, Ltd.
Generic for: Zyrtec Allergy Tablets and Zyrtec Hives Relief
Treatment for: Allergies

Technetium Tc-99m Mebrofenin Kit (Injection) 45 mg/vial
Approved: January 29, 2008 CIS-US, Inc.
Generic for: Choletec Kit For Injection
Treatment for: Diagnostic

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL
Approved: January 29, 2008 Outlook Pharmaceuticals, Inc.
Generic for: Dexedrine Oral Solution (Elixir)
Treatment for: Narcolepsy and Attention Deficit Hyperactivity Disorder (ADHD)

Calcium Acetate Tablets USP, 667 mg
Approved: January 30, 2008 Roxane Laboratories, Inc.
Generic for: Phoslo Tablets, 667 mg
Treatment for: Hyperphosphatemia of Renal Failure


Latest FDA MedWatch Alerts
MedWatch alerts provide safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration.

Tysabri (natalizumab)
February 27, 2008
Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients.

Denture Cleanser Allergic Reactions and Misuse
February 26, 2008
FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use.

Avandia (rosiglitazone maleate)
February 26, 2008
FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.

Fentanyl transdermal system CII Patches
February 19, 2008
Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labeled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.

Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches
February 15, 2008
PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin.

Heparin Sodium Injection (Baxter)
February 11, 2008
FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded.

Chattem Icy Hot Heat Therapy Products
February 11, 2008
Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation.

Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)
February 8, 2008
FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses.

Injectable Colchicine (including drugs containing colchicine)
February 6, 2008
FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously.

Varenicline (marketed as Chantix)
February 1, 2008
FDA informed healthcare professionals and consumers of important revisions to the Warnings and Precautions sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.

Antiepileptic Drugs
January 31, 2008
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%).

NuCel Labs Eye Drops and Eye-Ear Wash Products
January 31, 2008
NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile.

Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
January 25, 2008
FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.

Leukine (sargramostim)
January 24, 2008
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA).

More FDA Medwatch Alerts


Other Drug News
The latest Pharmaceutical News & Articles brought to you by

Agents Used for Treatment of Anemia Associated with Increased Risk of Blood Clots, Death in Patients with Cancer
February 26, 2008
Treating anemia with a class of drugs known as erythropoiesis-stimulating agents (ESAs) is associated with an increased risk of venous thromboembolism (blood clots in the deep veins of the legs or in the lungs) and death among patients with cancer, according to an article in the February 27 issue of JAMA.

Who Benefits from Antidepressants? US Health Inequities
February 25, 2008
A new study published today in PLoS Medicine suggests that antidepressants only benefit some, very severely depressed patients. "New generation" antidepressants, such as fluoxetine (Prozac) are widely prescribed for the treatment of clinical depression. However some studies have suggested that these drugs do not help the majority of depressed people get better by very much.

Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
February 22, 2008
Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market Humira (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older.

Missing Price Information Hampers Usefulness of State Prescription Drug Web Sites
February 13, 2008
Extensive gaps in price information seriously hamper the effectiveness of state drug price comparison Web sites, according to a study released today by the Center for Studying Health System Change (HSC). As of late 2007, 10 states had Web sites providing prescription drug prices available at retail pharmacies -- Connecticut, Florida, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York and Vermont.

More Americans Are Using More Prescription Drugs
February 13, 2008
More U.S. adults are taking prescription drugs than ever before, fueling $12 billion in additional spending during 2006 alone. The number of people with at least one prescription increased from 67% to 74% between 2000 and 2006, according to a new Geographic Variation in Prescription Utilization study by pharmacy benefit manager Express Scripts. The number of prescriptions per person rose to 14.3 from 10.8 in 2000 - a 32 percent jump.

U.S. Pharmacopeia 8th Annual MEDMARX Report Indicates Look-Alike/Sound-Alike Drugs Lead to Thousands of Medication Errors Nationwide
January 29, 2008
The 8th annual national MEDMARX Data Report released today by the U.S. Pharmacopeia (USP) revealed that more than 1,400 commonly used drugs are involved in errors linked to drug names that look alike or sound alike. According to findings in the MEDMARX report, 1.4% of the errors resulted in patient harm, including seven errors that may have caused or contributed to patient deaths.

FDA Approves Labeling Change for Non-Drowsy Claritin
January 22, 2008
Schering-Plough today announced that the U.S. Food and Drug Administration has approved additional labeling for Claritin (loratadine), which clearly tells consumers that the non-drowsy over-the-counter medication relieves allergy symptoms caused by both indoor (also called perennial or year-round) and outdoor (also called seasonal) allergies.

More News Headlines


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