Rituximab (Rituxan - IDEC Pharmaceutical/Genentech), a monoclonal antibody, has been approved by the FDA for treatment of low-grade B-cell non-Hodgkin's lymphoma. Most low-grade lymphomas are B-cell lymphomas.

Basiliximab (Simulect - Novartis) and daclizumab (Zenapax - Roche), two mouse/human monoclonal antibodies that block the interleukin-2 (IL-2) receptor on Tlymphocytes, have been approved by the FDA for use in the prevention of acute renal transplant rejection. Both drugs are used with cyclosporine (Sandimmune; Neoral) and corticosteroids. An all-murine anti-CD3 monoclonal antibody, muromonab-CD3 (Orthoclone OKT3), has been available in the USA for many years for treatment of transplant rejection, and has also been used with some success for prophylaxis (MI Wilde and KL Goa, Drugs,...

0.5% malathion in 78% isopropanol was recently approved by the FDA for treatment of head lice.

Cevimeline hydrochloride, an acetylcholine derivative, has been approved by the FDA for treatment of dry mouth symptoms caused by Sjogren's syndrome. Presumably it could also be used to treat radiation-induced xerostomia in patients with head and neck cancer. Pilocarpine hydrochloride is FDA-approved for both indications

Eflornithine hydrochloride cream 13.9% (Vaniqa - Bristol-Myers Squibb) has been approved by the FDA for reduction of unwanted facial hair in women.

Tegaserod maleate (Zelnorm – Novartis), a partial serotonin 5-HT4 receptor agonist that increases gastrointestinal motility, was approved by the FDA in 2002 for short-term treatment of constipation-predominant irritable bowel syndrome in women,1 and in 2004 for treatment of chronic constipation in adults ≤65 years old. Its efficacy has not been impressive statistically, but according to Medical Letter consultants some patients with slow-transit constipation have benefited from taking the drug. Diarrhea has been its main adverse effect.2The FDA now has requested that the manufacturer stop...

The drug of choice for patients who require parenteral treatment for malaria is IV artesunate, which is available now from the CDC Malaria Branch (M-F, 8 AM-4:30 PM eastern time, 770-488-7788 or, after hours, 770-488-7100). Artesunate appears to be more effective than quinine1 and safer than quinidine, the other parenteral alternatives in the US. The CDC has supplies of artesunate in Atlanta and in 8 quarantine stations in major airports around the US. It will release the drug for appropriate patients (severe disease or unable to take oral drugs) if it can be supplied as quickly as quinidine,...

Transcatheter aortic-valve replacement (TAVR), a procedure in which a prosthetic valve is inserted into the aortic annulus by a catheter, has been approved by the FDA as an alternative to surgical aortic-valve replacement for patients with severe symptomatic aortic stenosis who are considered inoperable.

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.

The FDA has approved tisagenlecleucel (Kymriah — Novartis), an individualized, genetically-modified cellular product, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≤25 years old. The patient's own T cells are genetically modified to express chimeric antigen receptors (CAR) and then reinfused. Kymriah is the first CAR T-cell immunotherapy to become available in the US. A CAR T-cell product for B-cell non-Hodgkin's lymphoma is expected to be approved soon.