The FDA has approved the marketing of Resperate (InterCure), a device that helps patients breathe slowly, as an adjunct for treatment of hypertension. The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.

The FDA has approved Trikafta (Vertex), a fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators elexacaftor, tezacaftor, and ivacaftor, for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who have at least one Phe508del mutation in the CFTR gene. About 90% of patients with CF have at least one copy of the Phe508del (also called F508del) mutation. This is the first approval for elexacaftor. Ivacaftor is available alone (Kalydeco) and in 2-drug combinations with tezacaftor (Symdeco) and lumacaftor...

The US Food and Drug Administration recently approved the marketing of a cervical cap (Prentif Cavity-Rim Cervical Cap - Lamberts Ltd, England), a contraceptive device that has been used in one form or another for many years (JP Koch, Contraception, 25:161, 1982). The cap is being distributed in the USA and Canada by Cervical Cap (CxC), Ltd, PO Box 38003-292, Los Gatos, CA 95031, telephone 408-358-6264; the distributor will make the caps available only to practitioners who have attended training seminars.

Pentostatin (2'-deoxycoformycin; DCF; - Parke-Davis), a purine analog, was recently approved by the US Food and Drug Administration (FDA) for treatment of hairy-cell leukemia resistant to interferon alfa (Intron A; Roferon-A). is a rare (500 cases/year in the USA) form of chronic lymphocytic leukemia. Acutely ill patients may respond rapidly to interferon, but the drug is rarely curative. Another purine analog, 2-chlorodeoxyadenosine (CdA; Leustatin - Ortho Biotech), may also be approved soon for treatment of hairy-cell leukemia (JD Piro, Blood, 79:843, 1992). Fludarabine (Fludara...

Growth hormone has been in the news recently because of accusations of criminal misconduct in some marketing and prescribing practices (G Kolata, New York Times, August 15, 1994, page 1). The high cost of the drug and its widespread use for unauthorized indications apparently were contributing factors.

The Prostatron, a microwave device manufactured by EDAP Technomed in Cambridge, MA, has been approved by the US Food and Drug Administration for treating symptoms of benign prostatic hyperplasia (BPH).

Tizanidine (Zanaflex - Athena Neurosciences) has been approved by the US Food and Drug Administration for oral treatment of increased muscle tone associated with spasticity. It has been available in Europe and Japan for 12 years as a short-term muscle relaxant.

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.