Bexxar, a combination of the monoclonal antibody tositumomab and radiolabeled Iodine-131 tositumomab (Corixa Corp/GlaxoSmithKline) has been approved by the FDA for a single treatment of relapsed follicular non-Hodgkin's lymphoma (NHL) in patients who are refractory to rituximab (Rituxan - Medical Letter 1998; 40:65). It is the second radioimmunoconjugate to be approved for refractory NHL; yttrium-90 linked to ibritumomab tiuxetan (Zevalin) was approved in 2002. Tositumomab, like ibritumomab, is a monoclonal antibody of mouse origin that binds to the CD20 antigen present on the surface of >90%...

The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults who are dependent on parenteral support.

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is the second nebulized LAMA to be approved for this indication; glycopyrrolate (Lonhala Magnair), which is administered twice daily with a portable handheld nebulizer, was the first.

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The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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Clozapine (Clozaril - Sandoz), an antipsychotic drug, was first marketed in the USA three years ago (Medical Letter, 32:3, 1990). Because of its hematological toxicity, the US Food and Drug Administration approved the drug only for patients with schizophrenia who cannot tolerate or do not respond to standard antipsychotic drugs.

Lasers have been used in dermatology for many years. Recently, however, improvements in laser technology have led to much wider use of lasers for treatment of cosmetic skin problems. Many different types of lasers are available; the US Food and Drug Administration gives manufacturers permission to market laser systems for specific indications.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.