RabAvert (Chiron), a new human rabies vaccine prepared in purified chick embryo cell culture (PCEC), has been marketed in the USA for pre- and post-exposure prophylaxis. It is available in other countries as Rabipur. Human rabies is rare in the United States, but thousands of people receive post-exposure prophylaxis every year (DL Noah et al, Ann Intern Med, 128:922, June 1, 1998).

The FDA has approved Tekamlo (Novartis), an oral fixed-dose combination of the direct renin inhibitor aliskiren (Tekturna) and the calcium channel blocker amlodipine (Norvasc, and others), for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and as initial therapy in those likely to need multiple drugs to control their blood pressure (BP). Both aliskiren and amlodipine are available in combinations with other antihypertensive agents.

Roflumilast (Daliresp – Forest), an oral phosphodiesterase 4 (PDE4) inhibitor, was approved by the FDA to reduce the risk of exacerbations in adult patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.

The FDA has approved a fixed-dose combination of the angiotensin receptor blocker (ARB) azilsartan and the thiazide-like diuretic chlorthalidone as Edarbyclor (Takeda) for treatment of hypertension

The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D mutation, which is found in about 5% of patients with CF. It is the first drug approved in the US that treats the cause of the disease.

Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) for treatment of metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. It is the same drug as aflibercept, which was approved last year as an intravitreal injection (Eylea) for treatment of neovascular (wet) agerelated macular degeneration (AMD). Ziv-aflibercept is the second VEGF inhibitor approved for treatment...

The FDA has approved telotristat ethyl (Xermelo – Lexicon), a tryptophan hydroxylase inhibitor, for use in combination with a somatostatin analog (SSA) for treatment of carcinoid syndrome diarrhea inadequately controlled with SSA therapy alone. Telotristat ethyl is the first oral drug to be approved in the US for this indication.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

The Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa), which was previously approved by the FDA for treatment of mantle cell lymphoma, Waldenström's macroglobulinemia, and relapsed or refractory marginal zone lymphoma, has now been approved for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults. The BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence) were approved earlier for treatment of CLL and SLL.