The FDA has approved vortioxetine (vor" tye ox' e teen; Trintellix – Takeda/Lundbeck), a new serotonergic drug, for treatment of major depressive disorder. Like vilazodone (Viibryd), another serotonergic antidepressant, it has been claimed to have a low incidence of sexual side effects and no significant effect on weight.

Lamotrigine (la mo tri jeen; Lamictal - Burroughs Wellcome), a phenyltriazine derivative, has been approved by the US Food and Drug Administration for use in addition to other antiepileptic drugs in adults with partial seizures. Since this diagnostic category includes the largest number of patients with intractable epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Lamotrigine was first marketed abroad in 1990 and is now available in more than 50 other countries.

The FDA has reported that 5106 elderly patients with dementia treated with atypical (second generation) antipsychotics in 17 randomized controlled trials had a higher mortality rate (4.5% vs. 2.6%) than those receiving placebo. Most of the deaths were due to cardiovascular and infectious causes (such as pneumonia). The drugs used in the trials were aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal). As the increase in mortality was considered a class effect, the FDA advisory also included ziprasidone (Geodon), clozapine (Clozaril) and the...

Aripiprazole (Abilify - Bristol-Myers Squibb/Otsuka), a second-generation (atypical) antipsychotic drug, was approved by the FDA in 2002 for treatment of schizophrenia and more recently for bipolar disorder as well. It has been promoted as causing fewer adverse effects than other antipsychotics, without sacrificing efficacy.

The FDA has approved valbenazine (Ingrezza – Neurocrine Biosciences), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of tardive dyskinesia in adults. It is the first drug to be approved in the US for this indication; two other VMAT2 inhibitors, tetrabenazine (Xenazine, and generics) and deutetrabenazine (Austedo), were approved earlier for treatment of chorea associated with Huntington's disease.

Zaleplon, a pyrazolopyrimidine hypnotic, was recently approved by the FDA for short-term treatment of insomia. Zaleplon, like zolpidem, is a non-benzodiazepine that binds to benzodiazepine receptors.

Botulinum toxin type A (Botox Cosmetic - Allergan) has received formal approval from the FDA for treatment of glabellar ("frown") lines in adults not more than 65 years old, and is being heavily advertised. Even before this approval, cosmetic use of botulinum toxin to reduce wrinkles on the face and neck had become a popular alternative to cosmetic surgery (Medical Letter 1999; 41:63). Botulinum toxin type A (Botox) and type B (Myobloc) are approved for treatment of cervical dystonia (Medical Letter 2001; 43:53), and type A has been approved since 1989 for treatment of strabismus and...

The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

Varenicline tartrate (Chantix - Pfizer) is now available for oral treatment of tobacco dependence. Some other drugs for this indication are listed in this article.

The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002;...