Terbinafine HCl (Lamisil drug Oral Granules, Novartis) has been approved for the treatment of tinea capitis, a fungal infection of the scalp, in children four years of age and older. Tinea capitis most commonly affects children and is often characterized by severe itching, dandruff, and bald patches. This contagious infection does not usually respond to topical treatment.

The granules can be sprinkled on food and are administered once a day for six weeks. The actual dosage is based on the child’s weight.

(Source: FDA, October 1, 2007.)

Millennium Pharmaceuticals has announced the FDA’s approval of bortezomib (Velcade), without dose adjustments, for use in patients with impaired kidney function, including patients who need dialysis. Impaired kidney function is a common complication related to multiple myeloma.

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Docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis), combined with cisplatin and 5-fluorouracil (5-FU), is now approved for induction therapy of locally advanced squamous cell carcinoma of the head and neck before patients undergo chemoradiotherapy and surgery.

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Patients with advanced breast cancer drug that has not responded to other anti-cancer drugs may soon have a new treatment option. Ixabepilone (Ixempra, Bristol-Myers Squibb) has been approved for use in combination with another cancer agent, capecitabine (generic Xeloda, Roche), in patients who no longer benefit from treatment with an anthracycline (such as doxorubicin [Adriamycin, Bedford]) and a taxane (such as paclitaxel [Taxol, Bristol-Myers Squibb] or docetaxel [Taxotere, Sanofi-Aventis]). Ixabepilone is also approved for use alone in patients who no longer benefit from an anthracycline, a taxane, and capecitabine.

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The FDA has granted marketing approval of Genzyme’s sevelamer carbonate (Renvela) for the control of serum phosphorus in patients with chronic kidney disease drug on dialysis.

Renvela is considered to be an improved version of Renagel (sevelamer HCl), a common phosphate binder.

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Raltegravir tablets (Isentress, Merck) have been approved for the treatment of human immunodeficiency virus drug (HIV)-1 infection, in combination with other anti-retroviral agents, in patients who have received other therapies and who have evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.

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Studies have shown that formulary restrictions can be an effective means of controlling drug use, but concerns have arisen about clinical consequences, say researchers from Canada. One retrospective study, for example, suggested that restricting fluoroquinolones drug could lead to more hospitalizations for pyelonephritis and bronchitis. To confirm these findings, the researchers conducted a study using a database of 1.4 million older adults.

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