An oral solution (Vituz – Hawthorne) containing two old drugs, the centrally-acting opioid hydrocodone bitartrate and the first-generation H1-antihistamine chlorpheniramine maleate, has been approved by the FDA for relief of cough and [other] symptoms associated with upper respiratory allergies or a common cold in adults. Several extended-release products containing hydrocodone and chlorpheniramine are available as capsules and suspensions and have been used for years for similar indications. Vituz is classified as a schedule III controlled substance, but the FDA has asked the DEA...

Metreleptin (Myalept – Amylin), a recombinant leptin analog produced in E. coli, has been approved by the FDA to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It has not been approved to date for the treatment of partial lipodystrophies, including those associated with the use of protease inhibitors in patients with HIV. Metreleptin is approved in Japan for the treatment of any lipodystrophy disorder.

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

Many drugs, mostly imidazole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis (Medical Letter, 33:81, 1991). Recently, fluconazole (Diflucan - Roerig), which is the drug of choice for treatment of oropharyngeal and esophageal candidiasis (Medical Letter, 36:16, 1994), was approved by the US Food and Drug Administration for single-dose oral treatment of .

Itraconazole (Sporanox - Janssen), an oral antifungal triazole that has been available in the USA since 1992 for treatment of deep fungal infections (Medical Letter, 35:7, 1993), is now being marketed for treatment of dermatophyte infections of the toenails, with or without fingernail involvement.

Caspofungin acetate(Cancidas) is the first of a new class of antifungals, the echinocandins. It has been approved by the FDA for treatment of invasive aspergillosis in patients who fail to respond to or are unable to tolerate other antifungal drugs such as amphotericin B and itraconazole.

Memantine hydrochloride, which has been used to treat dementia in Germany (Axura Merz) since 1982, has become the latest word-of-mouth miracle drug for Alzheimer's disease in the US (G Kolata, NY Times, June 15, 2003). Forest Laboratories has submitted a New Drug Application to the FDA for memantine. This review describes the standard treatment for Alzheimer's Disease, mechanism of action, clinical studies, adverse effects and dosage. Also included are sections on availability of the drug and how some people are obtaining memantine from abroad.

The FDA has required the manufacturer of Plavix, an antiplatelet drug used in addition to aspirin to prevent cardiovascular events in high-risk patients,1 to add a boxed warning to the package insert about the risk of a poor response to the drug in patients with genetic polymorphisms of the cytochrome P450 enzyme CYP2C19. Clopidogrel is a prodrug and CYP2C19 is mainly responsible for its bioactivation. The Medical Letter reported last year that several studies have found higher rates of cardiovascular events, including stent thrombosis, in patients with these polymorphisms taking...

The FDA has approved macitentan (ma" si ten' tan; Opsumit – Actelion), for oral treatment of pulmonary arterial hypertension (PAH). Macitentan is the second nonselective endothelin receptor antagonist approved for PAH. It is a derivative of bosentan (Tracleer), which is also manufactured by Actelion, and is scheduled to become available generically in 2015. Riociguat (Adempas), another new drug for this indication, will be reviewed in a future issue. Volibris

The FDA has approved miltefosine (Impavido – Knight Therapeutics), an oral alkylphosphocholine analog, for treatment of visceral, cutaneous, and mucosal leishmaniasis caused by some Leishmania species. It is the first drug to be approved by the FDA for treatment of cutaneous and mucosal leishmaniasis and the first oral drug to be approved for treatment of visceral leishmaniasis.