Gemifloxacin (Factive - Oscient), a new oral fluoroquinolone antibiotic, has been approved by the FDA for 5 days' treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) and 7 days' treatment of mild to moderate community-acquired pneumonia (CAP) in adults. For the next 6-8 months it will only be available, presumably for commercial reasons, in states east of the Rocky Mountains.

An extended-release formulation of carbamazepine, available since 1997 for treatment of epilepsy, has now been approved under a new name, Equetro, for acute mania and mixed episodes of bipolar disorder. Although the drug was effective in some patients for up to 6 months, it has not been approved for maintenance treatment. Carbamazepine has not been shown to be more effective than lithium or valproate, and it can cause serious adverse effects.

Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.

The FDA recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.

Ibandronate (Boniva - Roche) is the first bisphosphonate approved by the FDA for intravenous (IV) treatment of osteoporosis in postmenopausal women. It is given as a bolus injection once every 3 months. Ibandronate is also available as an oral once-a-month 150-mg tablet and as a daily 2.5-mg tablet.

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 oritavancin (Orbactiv – The Medicines Company), a long-acting lipoglycopeptide antibiotic given as a single intravenous (IV) dose, for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in adults. It is the third lipoglycopeptide antibiotic to be marketed in the US; telavancin (Vibativ) and dalbavancin (Dalvance) were approved earlier.

The FDA has approved Aptensio XR (Rhodes), an extended-release formulation of methylphenidate hydrochloride, for treatment of attention-deficit/hyperactivity disorder (ADHD). The Aptensio XR capsules contain multilayer beads designed to provide both a rapid onset and a long duration of action. This formulation of methylphenidate has been available in Canada as Biphentin since 2006.

The FDA has approved Namzaric (Forest), a fixed-dose combination of extended-release (ER) memantine (Namenda XR), an NMDA-receptor antagonist, and donepezil (Aricept, and generics), an acetylcholinesterase inhibitor, for treatment of moderate to severe Alzheimer's type dementia in patients previously stabilized on both drugs. The patent for Namenda has recently expired and generic formulations of memantine 5- and 10-mg tablets have been approved.

The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupilumab was approved earlier to treat adults with moderate to severe atopic dermatitis inadequately controlled with topical therapies.