August 14, 2007
Internal Medicine World Report, August 2007, Volume 0, Issue 0

Valsartan-Amlodipine Combination Tablet

A single-tablet combination of valsartan (Diovan) and amlodipine (Norvasc), Exforge (Novartis), has been approved for patients whose hypertension has not responded to angiotensin receptor blockers or calcium channel blockers, or those who experience dose-related side effects with either valsartan or amlodipine alone. www.novartis.com

First Patch for Alzheimer's

The rivastigmine transdermal system (Exelon Patch; Novartis) has received approval for mild-to-moderate Alzheimer's disease. The patch maintains steady plasma drug levels, which enhance tolerability. The patch can be applied to the back, chest, or upper arm. Efficacy is similar to that of the highest doses of oral rivastigmine. The target dose of 9.5 mg/24 hours has generally been well tolerated. www.novartis.com

1 Drug for 3 Sleep Disorders

Oral armodafinil (Nuvigil; Cephalon), a nonamphetamine agent, has received approval for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS; as an adjunct to standard treatment for the underlying obstruction), narcolepsy, and for shift work sleep disorder (SWSD). The recommended dosage for OSAHS or narcolepsy is 150 or 250 mg as a single dose in the morning; for SWSD, it is 150 mg, taken 1 hour before the start of work. Side effects include nausea, headaches, dizziness, diarrhea, decreased appetite, and upset stomach. www.cephalon.com

First Rapid Test for Malaria

Plasmodium falciparum

The Binax NOW Malaria Test (Binax) has become the only authorized US rapid test for malaria to be approved for laboratory use. The test provides results within 15 minutes and can differentiate from less-virulent malaria parasites. Results must still be confirmed with standard microscopic evaluation. www.cdc.gov/malaria

New Test for Metastatic Breast Cancer

The first molecular-based laboratory test for detecting whether breast cancer has metastasized to nearby lymph nodes has been approved. The GeneSearch BLN Assay (Veridex) detects molecules that are abundant in breast tissue but scarce in normal lymph nodes. www.veridex.com

Topical Foam for Seborrheic Dermatitis

Ketoconazole (Extina; Stiefel) foam 2% has been approved for the treatment of seborrheic dermatitis in immunocompetent patients aged ≥12 years. It is administered using VersaFoam-HF technology, which allows the drug to be quickly absorbed into the skin. Extina is applied to the affected areas twice a day (morning and evening) for 4 weeks. Adverse events include application-site burning. www.extina.com

First Artificial Cervical Disc

The Prestige Cervical Disc (Medtronic Sofamor Danek), the first artificial cervical disc, has been approved for the treatment of cervical degenerative disc disease. www.medtronic.com

Computerized Medication Box

The Electronic Medication Management Assistant (EMMA; INRange Systems), a programmable device that stores and dispenses prescription medications in the patient's home, has received marketing approval. EMMA may be especially useful in the elderly and in patients with complex medication regimens. www.inrangesystems.com/emma.html

New Indications/Dosages

  • Pregabalin (Lyrica; Pfizer): first medication indicated for the treatment of fibromyalgia. www.pfizer.com
  • Oseltamivir phosphate (Tamiflu; Roche): 30- and 45-mg capsules are now available for children aged ≥1 year, joining the already-approved 75-mg capsule for adults and the liquid suspension formulation for children. www.roche.com

Lamisil Goes Generic

The first generic version of prescription Lamisil (terbinafine hydrochloride) 250-mg tablets, used to treat nail fungus infection, has been approved. A generic version of OTC Lamisil cream (terbinafine hydrochloride 1%) to treat athlete's foot was also approved. www.fda.gov/cder/ogd/approvals