New products: June 16, 2008

New indications, formulations, drugs, generics and over the counter products



CV Therapeutics and Astellas Pharma US, Inc. announced that FDA has approved Lexiscan (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. MPI, also known as a cardiac stress test, detects and characterizes coronary artery disease. Almost half of the patients undergoing cardiac stress tests each year are unable to exercise adequately because of medical conditions. Lexiscan,, is delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight. The A2A adenosine receptor is the adenosine receptor subtype responsible for coronary vasodilation.


Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) has been approved for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. The FDA also expanded the use of the GlaxoSmithKline ( product to a broader patient population which includes not only patients with COPD associated with chronic bronchitis, but also emphysema or both conditions. The product was originally approved in 2003 for the maintenance treatment of airflow obstruction in patients with COPD.

Eli Lilly announced that Strattera (atomoxetine HCI) is now indicated for maintenance treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. Strattera, a selective norepin-ephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents, and adults. The drug was involved in an 18-month trial of 604 children and adolescents aged six to 15 years, and was shown to be superior to placebo in maintaining continuous efficacy in patients. More information can be found at

Another ADHD drug, Shire's Vyvanse (lisdexamfetamine dimesylate), has also received a new indication. The drug, which in July 2007 was approved for the treatment of ADHD in children aged 6 to 12 years, is now green-lighted to treat adults with ADHD.

Abilify (aripiprazole) can now be used as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults. The medication from Bristol-Myers Squibb and Otsuka Pharmaceutical had previously been approved as monotherapy for the treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults since 2004. In addition to this new indication, the FDA also approved a new recommended starting and target dose of 15 mg daily for Abilify ( monotherapy in the treatment of bipolar I disorder in adults.


Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa [Recombinant]) is a room-temperature stable recombinant drug for the treatment of bleeding episodes in patients with hemophilia with inhibitors. NovoSeven RT is a new formulation of NovoSeven (Coagulation Factor VIIa [Recombinant]) and has been manufactured to be room-temperature stable (from 36° F to 77° F outside a refrigerator). It can be moved in and out of the refrigerator and has a higher concentration for lower infusion volumes and quick administration.


The FDA has approved a new once-a-month dose of 150 mg for Actonel (risedronate sodium) tablets. The medication for the treatment and prevention of postmenopausal osteoporosis is approved to reduce the risk of fractures in postmenopausal women with osteoporosis. Actonel ( is co-promoted by the Alliance for Better Bone Health, an alliance between Procter & Gamble Pharmaceuticals and sanofi-aventis.