Volume 40 - December 2007

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

Kuvan (sapropterin dihydrochloride) Tablets
Date of Approval: December 13, 2007
Treatment for: Phenylketonuria
Kuvan is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). Kuvan is indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase.
Kuvan Drug Information | Press Release

Triesence (triamcinolone acetonide) Injectable Suspension
Date of Approval: November 29, 2007
Treatment for: Use in Eye Surgery
Triesence is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Triesence 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.

Thyrogen (thyrotropin alfa for injection)
New Indication Approved: December 14, 2007
Treatment for: Thyroid Cancer Ablation
Thyrogen contains a highly purified recombinant form of human thyroid stimulating hormone (TSH). Thyrogen was first approved in November 1998 for use as an adjunctive diagnostic tool in patients with thyroid cancer. Thyrogen is now also indicated for use in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed.
Thyrogen Drug Information | Press Release

Derma-Smoothe/FS (fluocinolone acetonide) Body Oil
Patient Population Altered: December 12, 2007
Treatment for: Atopic Dermatitis in Pediatric Patients 3 Months and Older
Derma-Smoothe/FS Body Oil contains a low to medium potency corticosteroid. Derma-Smoothe/FS was first approved in February 1988 for the treatment of atopic dermatitis in adults and has since been approved for use in children as young as two years. Derma-Smoothe/FS is now also indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks.
Derma-Smoothe/FS Drug Information

Cymbalta (duloxetine) Delayed-Release Capsules
New Indication Approved: November 28, 2007
Treatment for: Maintenance Treatment of Major Depressive Disorder
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta was first approved in August 2004 for the acute treatment of major depressive disorder and has since been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and for the acute treatment of generalized anxiety disorder. Cymbalta is now also approved for the maintenance treatment of major depressive disorder (MDD) in adults.
Cymbalta Drug Information | Press Release

Omnaris (ciclesonide) Nasal Spray
Patient Population Altered: November 21, 2007
Treatment for: Seasonal Allergic Rhinitis in Patients 6-12 Years
Omnaris is an intranasal corticosteroid. Omnaris Nasal Spray was first approved in October 2006 for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older. Omnaris is now also approved for seasonal allergic rhinitis in children 6 through less than 12 years of age.
Omnaris Nasal Spray Drug Information

Diovan (valsartan) Tablets
Patient Population Altered: November 29, 2007
Treatment for: Hypertension in Patients 6-16 Years
Diovan is an angiotensin II receptor antagonist. Diovan was first approved in December 1996 for the treatment of hypertension in adult patients and has since been approved for the treatment of heart failure and post-myocardial infarction. Diovan is now also approved for the treatment of hypertension (high blood pressure) in children and adolescents ages six to 16.
Diovan 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.

Oxycodone Hydrochloride and Ibuprofen Tablets 5 mg/400 mg
Approved: November 26, 2007 Watson Laboratories, Inc.
Generic for: Combunox Tablets


Latest FDA MedWatch Alerts
MedWatch alerts are concerning pharmaceuticals already released in the USA and are issued by the FDA.

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]

December 14, 2007
Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots.

Exjade (deferasirox) Tablets For Oral Suspension
December 13, 2007
Novartis informed healthcare professionals of changes made to the WARNINGS, ADVERSE REACTIONS, and DOSAGE and ADMINISTRATION sections of prescribing information for Exjade Tablets for Oral Suspension. The WARNINGS and ADVERSE REACTIONS sections of the labeling were revised to include information about postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure.

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)
December 12, 2007
FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine.

Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)
December 4, 2007
FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures.

Myfortic (mycophenolic acid) Delayed Release Tablets
November 27, 2007
Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk).

More FDA Medwatch Alerts


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

Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
December 18, 2007
Forest Laboratories, Inc. and Mylan Inc. announced today that the novel beta blocker Bystolic (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments.

FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription Mevacor (lovastatin) 20 mg
December 13, 2007
Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's (FDA) joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval at this time of the over-the-counter (OTC) use of Mevacor (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.

Cholesterol-Lowering Drugs and the Risk of Hemorrhagic Stroke
December 12, 2007
People taking cholesterol-lowering drugs such as atorvastatin after a stroke may be at an increased risk of hemorrhagic stroke, or bleeding in the brain, a risk not found in patients taking statins who have never had a stroke. But researchers caution the risk must be balanced against the much larger overall benefit of the statin in reducing the total risk of a second stroke and other cardiovascular events when making treatment decisions. The research is published in the December 12, 2007, online issue of Neurology, the medical journal of the American Academy of Neurology.

Use of Diabetes Medication by Older Adults Associated with Increased Risk of Serious Heart Problems, Death
December 11, 2007
Older patients treated with the diabetes medications known as thiazolidinediones (which include rosiglitazone) had a significantly increased risk of heart attack, congestive heart failure and death, compared with the use of other hypoglycemic drugs, according to a study in the December 12 issue of JAMA. The authors suggest that these results provide further evidence that this class of medication may cause more harm than good.

New Report Offers Hope for Closing Health Gap for African Americans, With Nearly 700 Medicines in Pipeline
December 10, 2007
The Pharmaceutical Research and Manufacturers of America (PhRMA) delivered a new report on medicines in the research pipeline for major diseases affecting African Americans to Mississippi Governor Haley Barbour today. The report found that America's pharmaceutical research companies are now testing 691 new medicines to help treat diseases that disproportionately affect African Americans or diseases that are among the top 10 causes of death among African Americans. According to the U.S. Census Bureau, Mississippi has the largest (37 percent) African American population in the United States.

Thalidomide Added to Standard Therapy Prolongs Overall Survival in Newly Diagnosed Multiple Myeloma Patients Over Age 75
December 9, 2007
Pharmion Corporation today announced final data from a randomized, double-blind, placebo-controlled Phase 3 trial demonstrating that the addition of Thalidomide to standard treatment improves survival by 17.6 months in patients over age 75 newly diagnosed with multiple myeloma compared to standard treatment, consisting of melphalan-prednisone (MP), alone.

Nationwide Survey Reveals Differing Physician and Patient Perceptions Regarding Impact of Ulcerative Colitis on Patients' Lives
December 7, 2007
Nearly three out of four patients with ulcerative colitis (UC) consider feeling unwell to be a normal part of life, while gastroenterologists estimate this to be true for only 37 percent of their UC patients, according to results from a nationwide series of surveys presented today at the 2007 Crohn's & Colitis Foundation's 6th Annual Advances in the Inflammatory Bowel Diseases conference.

More News Headlines


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