New protease inhibitor offers patients efficacy, convenience
November 17th 2003Clinicians will soon be able to offer HIV-positive patients a protease inhibitor (PI) that combines the convenience of flexible dosing with no restrictions on food or water. The FDA recently approved fosamprenavir (Lexiva, GlaxoSmithKline/Vertex Pharmaceuticals) for the treatment of HIV infection in adults in combination with other antiretroviral agents. Fosamprenavir will be available in pharmacies later this month.
First selective aldosterone-blocker now approved for CHF
November 3rd 2003Clinicians will soon be able to offer their patients the first aldosterone-receptor blocker to be approved for the treatment of congestive heart failure (CHF). The FDA recently approved eplerenone (Inspra, Pfizer) to improve the survival of stable patients with left ventricular systolic dysfunction and clinical evidence of CHF following an acute myocardial infarction (MI).
First in new class of antibiotics gets FDA nod
October 20th 2003Clinicians will soon be able to treat serious bacterial infections using the first cyclic lipopeptide agent to receive FDA approval. The FDA recently approved daptomycin (Cubicin, Cubist Pharmaceuticals) for injection for the treatment of complicated skin and skin structure infections caused by susceptible strains of Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-resistant strains only). Daptomycin is not indicated for the treatment of pneumonia. According to the manufacturer, daptomycin is expected to be available in hospitals in early November.
Extended-cycle OC offers more convenience
October 6th 2003Clinicians can soon offer women the convenience of an extended-cycle oral contraceptive (OC). The FDA recently approved levonorgestrel/ethinyl estradiol (Seasonale, Barr Laboratories) 0.15 mg/0.03 mg tablets for the prevention of pregnancy. The manufacturer plans a November 1 launch for Seasonale, the first extended-cycle OC to receive FDA approval.
Hear ye: New eardrop packs combo punch
October 6th 2003Clinicians will soon be able to offer the parents of children with common ear infections the first ototopical therapy that combines the antibacterial activity of ciprofloxacin and the antiinflammatory properties of dexamethasone. The FDA recently approved ciprofloxacin, 0.3% and dexamethasone, 0.1% (Ciprodex, Alcon) sterile otic suspension for the treatment of acute otitis media due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa in children age six months and older with tympanostomy tubes. Ciprodex was also approved for the treatment of acute otitis externa due to Staphylococcus aureus and Pseudomonas aeruginosa in children age six months and older, adults, and older persons.