The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.

Quetiapine (Seroquel - Zeneca), a dibenzothiazepine derivative, has been approved by the FDA for treatment of schizophrenia and other psychotic disorders. It is a new addition to the 'atypical' antipsychotics, which include olanzapine (Zyprexa - Medical Letter, 39:5, 1997), risperidone (Risperdal) and clozapine (Clozaril). Atypical antipsychotic drugs generally are less likely to cause extrapyramidal symptoms than older drugs such as haloperidol (Haldol, and others) or the phenothiazines.

Cevimeline hydrochloride, an acetylcholine derivative, has been approved by the FDA for treatment of dry mouth symptoms caused by Sjogren's syndrome. Presumably it could also be used to treat radiation-induced xerostomia in patients with head and neck cancer. Pilocarpine hydrochloride is FDA-approved for both indications

The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

The FDA has approved lurasidone (Latuda - Sunovion), a new second-generation antipsychotic, for oral treatment of schizophrenia in adults.

Invega Hafyera (Janssen), a long-acting, extended-release (ER) formulation of the second-generation antipsychotic paliperidone palmitate, has been approved by the FDA for twice-yearly IM treatment of schizophrenia in adults who have been adequately treated with another injectable ER formulation of the drug (Invega Sustenna or Invega Trinza). It is the first drug to become available in the US for twice-yearly treatment of schizophrenia.

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.

Tramadol hydrochloride (Ultram - Ortho-McNeil), a centrally-acting analgesic marketed in Germany since 1977, was recently approved by the US Food and Drug Administration for oral treatment of moderate to moderately severe pain. Despite some opioid activity, tramadol has not been scheduled as a controlled substance.

A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD) dementia. Donepezil is the second acetylcholinesterase inhibitor to become available in a transdermal formulation; transdermal rivastigmine (Exelon Patch), which is applied once daily, has been available for years for the same indication. Donepezil is also available in oral formulations (Aricept, and generics) for treatment of AD dementia.

Nebivolol (Bystolic - Forest) is a new beta-blocker that has been approved by the FDA for treatment of hypertension. It has been marketed in Europe since 1999 for treatment of hypertension and heart failure.