Mirtazapine (mir taz a peen; Remeron - Organon) has been approved by the US Food and Drug Administration for treatment of depression. A tetracyclic piperazinoazepine, it is an analog of mianserin, an antidepressant available in Europe, but is structurally unrelated to antidepressants previously available in the USA.

The FDA has approved over-the-counter (OTC) sale of the weight-loss drug orlistat (Xenical – Roche)1 as alli (GlaxoSmithKline), to be used in combination with a reduced-calorie, low-fat diet. Orlistat binds to gastric and pancreatic lipases, preventing absorption of about 30% of dietary fat with the 120-mg prescription dose, and 25% with the 60-mg OTC dose. A 16-week controlled trial of the OTC dose (60 mg 3 times daily with meals) in overweight, not obese, patients (average BMI 26.8) on a reduced-calorie, low-fat diet found that patients taking the drug lost 1.15 kg more than those taking...

The FDA has received new reports of serious and life-threatening hypersensitivity reactions to omalizumab (Xolair – Genentech), a monoclonal anti-IgE antibody injected subcutaneously for treatment of asthma (Med Lett Drugs Ther 2003; 45:67), and has added a black-box warning to the package insert.Postmarketing reports submitted to the FDA included 124 reports of anaphylaxis among an estimated 57,300 patients (0.2%) who might have been treated with the drug between June 2003 and December 2006. Anaphylaxis occurred after the first dose of Xolair in 39% of cases, after a 2nd dose in 19%, after...

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

Sebetralstat (Ekterly – Kalvista), an oral plasma kallikrein inhibitor, has been approved by the FDA for treatment of acute hereditary angioedema (HAE) attacks in patients ≥12 years old. It is the first oral drug to be approved in the US for this indication. The intravenous C1 esterase inhibitors (C1INHs) Berinert and Ruconest, the subcutaneous plasma kallikrein inhibitor ecallantide (Kalbitor), and the subcutaneous bradykinin B2 receptor antagonist icatibant (Firazyr) have been available for years for on-demand treatment of HAE attacks; all of these drugs except ecallantide can...

Linezolid, the first of a new class of antibiotics, the oxazolidinones, has been marketed for treatment of infection due to vancomycin-resistant Enterococcus faecium, nosocomial and community-acquired pueumonia due to Staphylococcus aureus or penicillin-sucsceptible Streptococcus pneumoniae, and skin and skin structure infections, including those due to methicillin-resistant S. aureus (MRSA).

The injectable interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults; it was approved earlier for treatment of ulcerative colitis (UC), plaque psoriasis, and psoriatic arthritis. The IL-23 antagonists risankizumab (Skyrizi) and mirikizumab (Omvoh) and the IL-12/23 antagonist ustekinumab (Stelara, and biosimilars) are also approved for treatment of CD.

Yutrepia (Liquidia), a dry powder inhaler formulation of the prostacyclin analog treprostinil, has been approved by the FDA to improve exercise ability in adults with pulmonary arterial hypertension (PAH; WHO Group 1) or pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). Tyvaso DPI, another treprostinil dry powder inhaler, was approved earlier for the same indication.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.