Anistreplase (Eminase - SmithKline Beecham, Upjohn), a plasminogen activator also known as APSAC, was recently approved by the US Food and Drug Administration (FDA) for intravenous (IV) thrombolytic treatment of coronary thrombosis. Three other thrombolytic agents - intracoronary urokinase (Abbokinase) and intracoronary or intravenous streptokinase (Streptase; Kabikinase) and alteplase (TPA; Activase)- were previously approved for coronary thrombolysis (Medical Letter, 29:107, 1987).

Loracarbef (Lorabid - Lilly), a new beta-lactam antibiotic with antimicrobial activity similar to the second-generation cephalosporins, has been approved by the US Food and Drug Administration for treatment of respiratory, skin, and urinary tract infection caused by susceptible organisms in both adults and children. It will probably compete with drugs such as trimethoprim-sulfamethoxazole (Bactrim, Septra, and others), amoxicillin-clavulanic acid (Augmentin), cefaclor (Ceclor), cefuroxime axetil (Ceftin), and cefprozil (Cefzil - Medical Letter, 34:63,...

The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile rheumatoid arthritis or Still’s disease) in children ≥2 years old. Canakinumab was approved earlier for treatment of cryopyrin-associated periodic syndromes (CAPS). Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor that has been available since 2010 for treatment of rheumatoid arthritis in adults, was also recently approved by the FDA for sJIA. Canakinumab is the only IL-1 inhibitor approved...

The FDA has approved vortioxetine (vor" tye ox' e teen; Trintellix – Takeda/Lundbeck), a new serotonergic drug, for treatment of major depressive disorder. Like vilazodone (Viibryd), another serotonergic antidepressant, it has been claimed to have a low incidence of sexual side effects and no significant effect on weight.

The FDA has approved Altuviiio (Sanofi), a von Willebrand Factor (VWF)-independent, recombinant factor VIII concentrate, for routine prophylaxis, on-demand treatment to control bleeding episodes, and perioperative management of bleeding in children and adults with hemophilia A. The manufacturer claims that Altuviiio, which was previously called efanesoctocog alfa, delivers normal to near-normal factor VIII levels for most of the week with once-weekly intravenous dosing.

The FDA has approved ustekinumab-auub (Wezlana – Amgen), an interchangeable biosimilar product similar to the interleukin-12 and -23 antagonist Stelara, for treatment of the same indications as Stelara (see Table 1). Wezlana is the first Stelara biosimilar to be approved in the US.

Recently, full-page advertisements have appeared in the New York Times and other newspapers promoting the Viralizer (Viral Response Systems, Greenwich, CT), a heated nebulizer-sprayer device marketed for treatment of colds, sore throats, allergy and sinusitis symptoms. The device is available without a prescription for about $30 to $40.

Bacterial infections of the conjunctivae are usually self-limited, but topical antimicrobial therapy can be helpful. A solution of trimethoprim sulfate 0.1% with polymyxin B sulfate 10,000 units/ml (Polytrim - Burroughs Wellcome, distributed by Allergan) was recently marketed in the USA for treatment of superficial ocular bacterial infections.

An oral formulation of mesalamine (5-aminosalicylic acid, 5-ASA, Asacol - Proctor & Gamble), was recently approved by the US Food and Drug Administration (FDA) for treatment of mildly to moderately active ulcerative colitis; it has not been approved for maintenance of remissions. Olsalazine (Dipentum), a similar drug (Medical Letter, 32:105, 1990), is approved for maintenance of remissions but not for treatment.

Dalteparin (Fragmin - Pharmacia), the second low-molecular-weight heparin to be marketed in the USA, is now available for prevention of deep vein thrombosis in high-risk patients after abdominal surgery. Enoxaparin (Lovenox -Rh ne-Poulenc Rorer) was approved in 1993 for prevention of deep vein thrombosis after hip replacement (Medical Letter, 35:75, 1993) and later approved for use in knee replacement. Five other low-molecular-weight heparins and one heparinoid are under investigation in the USA (MJ Cziraky and SA Spinler, Clin Pharm, 12:892, 1993).