The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative colitis.

The FDA has approved a rectal foam formulation of the corticosteroid budesonide (Uceris - Salix/Valeant) for induction of remission in patients with active mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. Budesonide is also available as oral extended-release tablets (also branded as Uceris) for use in patients with UC and as oral enteric-coated tablets (Entocort EC, and generics) for treatment of Crohn's disease.

Artesunate for injection (Amivas LLC), a semi-synthetic artemisinin derivative, is now approved by the FDA for initial (induction) treatment of severe malaria in children and adults. It has been available from the CDC on a compassionate use basis since 2007. Artemether/lumefantrine (Coartem), another artemisinin-based drug, was approved earlier for oral treatment of uncomplicated Plasmodium falciparum malaria. IV artesunate is now the only FDA-approved injectable antimalarial drug available in the US; IV quinidine has been discontinued.

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.