FDA actions in brief

Peginterferon alfa-2a (Pegasys, Roche) and ribavirin (Copegus, Roche) were approved in combination for the treatment of chronic hepatitis C in patients coinfected with HIV who have clinically stable HIV disease.

FDA approved candesartan (Atacand, AstraZeneca) for the treatment of heart failure to reduce the risk of death from cardiovascular causes and reduce hospitalizations from heart failure.

Temozolomide (Temodar, Schering-Plough) was approved for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM).

Approval was denied for escitalopram (Lexapro, Forest) for the treatment of panic disorder.

An extended-release formulation of desloratadine and pseudoephedrine (Clarinex-D 24 Hour, Schering-Plough) was approved for once-daily relief of nasal and non-nasal symptoms of seasonal allergic rhinitis in patients aged 12 years and older. The new formulation contains 5 mg of desloratadine and 240 mg of pseudoephedrine.

FDA approved revised labeling for rosuvastatin (Crestor, AstraZeneca) based on 15 months of post-marketing surveillance. The revised labeling includes additional information about adverse events associated with the drug and more explicit instructions for physicians to reserve the use of the 40-mg dose for patients who have not achieved their LDL-C goal with the 20-mg dose.

Aripiprazole (Abilify, Bristol-Myers Squibb/Otsuka) was approved for maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks.

FDA approved 2 new dosage strengths of atomoxetine (Strattera, Lilly). The attention-deficit/hyperactivity (ADHD) disorder therapy is now available in 80- and 100-mg capsules.

Levalbuterol in a hydrofluoroalkane metered-dose inhaler (Xopenex HFA, Sepracor) was approved for the treatment or prevention of bronchospasm in adults, adolescents, and children aged 4 years or older with reversible obstructive airway disease.

FDA approved a new preservative-free formulation of flu vaccine (Fluzone, Sanofi-Aventis) for use in children aged 6 to 35 months. The new formulation will replace the previous pediatric versions of the vaccine, which contained trace amounts of the mercury-based preservative thimerosal.

Sodium benzoate/sodium phenylacetate solution (Ammonul, Medicis) was approved as an adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

A liquid formulation of somatropin (rDNA origin) injection (Serostim LQ, Serono) was approved by FDA. The therapy is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight and to improve physical endurance.