The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of venous thromboembolism (VTE) after elective hip arthroplasty, but was only marketed recently in the US. It has been available in Europe as Revasc for about 10 years. Two other hirudin analogs are available in the US: lepirudin (Refludan) for treatment of heparin-induced thrombocytopenia (HIT) and bivalirudin (Angiomax) for use in percutaneous coronary intervention (PCI).

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.

The FDA has approved Haegarda (CSL Bering), a human plasma-derived C1 esterase inhibitor (C1INH), for prophylaxis against hereditary angioedema (HAE) attacks in adolescents and adults. Haegarda is the fourth C1INH to be approved by the FDA and the second to be approved for HAE prophylaxis. Unlike the other C1INHs, Haegarda is self-administered subcutaneously rather than intravenously.

The FDA has approved ibalizumab-uiyk (Trogarzo – Theratechnologies/TaiMed), a CD4-directed monoclonal antibody, for IV treatment of multidrug-resistant HIV-1 (MDR-HIV) infection in heavily antiretroviral-experienced adults with treatment failure on their current regimen. Ibalizumab-uiyk is the first biologic drug to be approved by the FDA for treatment of HIV-1 infection.

Felbamate (Felbatol - Wallace Laboratories), a phenyl dicarbamate structurally similar to meprobamate (Equanil, and others), was recently approved by the US Food and Drug Administration for use alone or with other drugs in adults with partial seizures with or without secondary generalization. It was also approved for use in addition to other drugs in children with the multiple types of seizures associated with the Lennox-Gastaut syndrome, a severe epileptic encephalopathy.

Lamotrigine (la mo tri jeen; Lamictal - Burroughs Wellcome), a phenyltriazine derivative, has been approved by the US Food and Drug Administration for use in addition to other antiepileptic drugs in adults with partial seizures. Since this diagnostic category includes the largest number of patients with intractable epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Lamotrigine was first marketed abroad in 1990 and is now available in more than 50 other countries.

Zafirlukast (za fir loo kast; Accolate - Zeneca), the first leukotriene receptor anta-gonist approved by the US Food and Drug Administration, is now being heavily promoted for oral maintenance treatment of chronic asthma in patients more than 12 years old. It is not recommended for treatment of acute asthma.

Fenoldopam mesylte (Corlopam - Neurex), a peripheral dopamine-1 (DA₁) agonist, has been approved by the FDA for parenteral use in lowering blood pressure. The manufacturer claims that, unlike other parenteral antihypertensive agents, fenoldopam not only lowers blood pressure but also maintains or improves renal function.

Dofetilide (Tikosyn - Pfizer), a new methanesulfonamide antiarrhythmic drug, has recently been marketed for oral treatment of atrial fibrillation and flutter.

Bivalirudin is being promoted as an intravenous (IV) anticoagulant that can be used instead of heparin in patients with unstable angina undergoing coronary angioplasty.