The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid decline in kidney function. Terlipressin is the first drug to be approved for this indication in the US; it has been available in Europe and elsewhere for year

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

With increasing travel, immigration, use of immunosuppressive drugs and the spread of AIDS, physicians anywhere may see infections caused by parasites. The table in this document lists first-choice and alternative drugs for most parasitic infections.

Cefuroxime axetil (Ceftin - Glaxo), an oral form of the second-generation parenteral cephalosporin cefuroxime (Zinacef), was recently marketed in the USA. Previously available oral cephalosporins are the first-generation drugs cephalexin (Keflex; and others), cephradine (Anspor; and others) and cefadroxil (Duricef; and others), and the second-generation cefaclor (Ceclor); second-generation cephalosporins have more activity against gram-negative bacteria.

Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.

Ketorolac (kee'; toe role ak) tromethamine (Toradol), manufactured by Syntex but also marketed by Roche, is the first parenteral nonsteroidal anti-inflammatory drug (NSAID) to become available for analgesic use in the USA. Parenteral indomethacin (Indocin I.V.) has been marketed here since 1985, but only for treatment of patent ductus arteriosus in newborn infants. Other parenteral NSAIDs are available in other parts of the world, but low potency, poor aqueous solubility, and substantial tissue irritation on injection have limited their usefulness. Ketorolac has been approved by the US ...

immune globulin (human) has been available for many years in an intramuscular (IM) formulation for prevention of Rh isoimmunization in pregnant Rh-negative women (Medical Letter, 16:3, 1974). Recently, the US Food and Drug Administration (FDA) approved the first intravenous (IV) immune globulin preparation (WinRho SD - Univax), not only for preventing Rh isoimmunization, but also for treatment of immune thrombocytopenic purpura (ITP) in Rh-positive patients.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.

The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002;...