Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

Cefprozil (Cefzil - Bristol-Myers Squibb), a new oral second-generation cephalosporin, was recently released in the USA for treatment of pharyngitis, bronchitis, otitis media, and skin and skin-structure infections.

Enoxaparin (Lovenox - Rh ne-Poulenc Rorer), the first low-molecular-weight heparin to become commercially available in the USA, was recently approved by the US Food and Drug Administration for prevention of deep vein thrombosis following hip replacement. Five other products have been marketed in Europe.

Valsartan (Diovan - Novartis), a non-peptide tetrazole, is the second angiotensin II receptor antagonist approved for oral treatment of hypertension by the US Food and Drug Administration. The first was losartan (Cozaar - Medical Letter, 37:57, 1995).

Methylphenidate is now available in a new extended-release formulation (Metadate CD - Celltech) for treatment of attention deficit/hyperactivity disorder (ADHD). The new product, which is a Schedule II controlled substance, is being advertised directly to consumers.

A recently published retrospective cohort study in patients 30-74 years old has led to headlines in the media warning that use of atypical antipsychotic drugs doubles patients’ risk of sudden cardiac death. Typical antipsychotics have long been associated with this risk. In this study, however, the incidence of sudden cardiac death was similar with typical and atypical antipsychotics: about 1 in 340 person-years among the patients who took typical (first generation) antipsychotics such as haloperidol (Haldol, and others) and 1 in 360 personyears among those who took atypical...

Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.

The FDA has approved macitentan (ma" si ten' tan; Opsumit – Actelion), for oral treatment of pulmonary arterial hypertension (PAH). Macitentan is the second nonselective endothelin receptor antagonist approved for PAH. It is a derivative of bosentan (Tracleer), which is also manufactured by Actelion, and is scheduled to become available generically in 2015. Riociguat (Adempas), another new drug for this indication, will be reviewed in a future issue. Volibris

The FDA has approved panobinostat (Farydak – Novartis), an oral histone deacetylase (HDAC) inhibitor, for use in combination with bortezomib (Velcade) and dexamethasone for treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory drug. It is the first HDAC inhibitor to be approved for this indication.

The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.