The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

Recombinant interferon alfa-2b (Intron A - Schering) was recently approved by the US Food and Drug Administration (FDA) for intralesional treatment of genital warts (condylomata acuminata). Interferon was previously available only for treatment of hairy-cell leukemia (Medical Letter, 28:78, 1986).

Pravastatin (Pravachol - Bristol-Myers Squibb) and simvastatin (Zocor - Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have been marketed in Canada and several European countries and may soon be available in the USA for treatment of high plasma cholesterol concentrations. Drugs already marketed here for this indication were recently reviewed in The Medical Letter (Volume 33, page 1, January 11, 1991).

Combination antiretroviral therapy including protease inhibitors has dramatically changed the treatment of HIV infection and the prognosis of those affected (Medical Letter Handbook of Antimicrobial Therapy, 1998, page 122). Due to limitations and failures with these drugs in many patients, however, three new drugs, none of them protease inhibitors, have rapidly come into wide use in clinical trials or 'expanded access' programs. They are abacavir (Ziagen - Glaxo Wellcome), adefovir (Preveon - Gilead) and efavirenz (Sustiva - DuPont). Efavirenz was recently approved for treatment of...

Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least four years old.

FluMist (MedImmune), the first live-attenuated and first intranasally administered influenza vaccine, has been approved by the FDA to prevent influenza in healthy people 5-49 years old. Given as a nasal spray, it stimulates immunity by viral replication in the upper respiratory tract. This vaccine apparently will be advertised directly to the public as a "needle-free" alternative to intramuscular influenza vaccine.

Two new fluoroquinolone solutions, moxifloxacin 0.5% (Vigamox - Alcon) and gatifloxacin 0.3% (Zymar - Allergan) are now available in the US for ophthalmic use in treatment of bacterial conjunctivitis.

Vytorin, a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe (Zetia - Merck/Schering Plough) and the HMG-CoA reductase inhibitor ("statin") simvastatin (Zocor - Merck), has been approved by the FDA for treatment of hypercholesterolemia. It is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin.

The FDA has approved marketing of the corticosteroid mometasone furoate in an orally inhaled dry powder formulation (Asmanex Twisthaler - Schering-Plough) for maintenance treatment of asthma in patients at least 12 years old. Mometasone is also available as a mid-potency topical corticosteroid cream (Elocon) and as an intranasal spray (Nasonex) for treatment of allergic rhinitis.