An intranasal spray formulation of the topical corticosteroid mometasone furoate, marketed for treatment of seasonal and perennial allergic rhinitis, has been advertised on television directly to the public.

A new needle-free system (cool.click) has been approved by the FDA for subcutaneous delivery of Saizen (recombinant somatotropin - Serono). Somatotropin is used for long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Children with growth hormone deficiency require injections daily or several times weekly for many years.

With the coming of spring, direct-to-consumer (DTC) advertisements in newspapers, in magazines and on television are urging people with seasonal allergies to ask their doctors about one or another of the newer, non-sedating antihistamines.

Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

Caduet (Pfizer), a combination of the calcium-channel blocker amlodipine (Norvasc - Pfizer) and the HMG-CoA reductase inhibitor (statin) atorvastatin (Lipitor - Pfizer), is now available in the US. It was approved by the FDA for use in patients with indications for treatment with both amlodipine, which is used to treat hypertension and/or angina pectoris, and atorvastatin, which is used to treat dyslipidemia. The combination is bioequivalent to the 2 components taken separately.

The FDA has approved a nasal spray formulation of fentanyl (Lazanda – Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.

Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis. An orally inhaled dry powder formulation of the aminoglycoside antibiotic tobramycin (Tobi Podhaler – Novartis) has been approved by the FDA for management of P. aeruginosa pulmonary infection in cystic fibrosis patients ≥6 years old. The new formulation is administered via a hand-held pocket-sized inhaler. Tobramycin is also available as an...

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. Encorafenib was approved in 2018 for use with the mitogen-activated kinase (MEK) inhibitor binimetinib (Mektovi) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.