FDA Rounds

October 16, 2007
Internal Medicine World Report, October 2007, Volume 0, Issue 0

Second-Generation Smallpox Vaccine

A new smallpox vaccine, ACAM2000 (Acambis), has received FDA approval and will be added to the CDC's Strategic National Stockpile of medical supplies designated for a bioterrorist attack. ACAM2000 is made from the pox virus, vaccinia, which is related to but different from the virus that causes smallpox. The live vaccine is derived from a clone of the only smallpox vaccine currently available, Dryvax, which is no longer being manufactured, and supplies are limited. www.acanbis.com

Injectable for Acromegaly

The FDA approved ianreotide acetate injection (Somatuline Depot; Tercica) for long-term treatment of acromegaly in patients who have had inadequate response to or cannot be treated with surgery and/or radiation therapy. The recommended dose is 90 mg every 4 weeks for the first 3 months, then adjusted based on patient response. Side effects include diarrhea, gallstones, injection-site reactions, decreased heart rate, hyper/hypoglycemia. www.somatulinedepot.com

New Topical Human Thrombin

Evithrom (Omrix Biopharmaceuticals), the first human thrombin approved since 1954, is now the only product licensed for controlling oozing and minor bleeding from capillaries and small veins and when standard surgical techniques to control bleeding are ineffective or impractical. www.omrix.com

New Indications

  • Risperidone (Risperdal; Janssen): for the treatment of schizophrenia in adolescents (13-17 years) and for short-term treatment of manic or mixed episodes of bipolar disorder, starting with children aged 10 and up. www.risperdal.com
  • Reclast (Novartis): as the first once-yearly treatment (as a single 5-mg injection) for postmenopausal osteoporosis. The active ingredient, zoledronic acid, is also available as a 4-mg infusion (Zometa) for the treatment of certain cancers. www.novartis.com
  • Raloxifene (Evista): for prevention of invasive breast cancer in postmenopausal women who are at high risk for invasive breast cancer. www.evista.com
  • Levofloxacin (Levaquin; Ortho-McNeil), 750 mg/day, IV and oral: for a 5-day course, once-daily treatment of complicated urinary tract infections and acute pyelonephritis. www.levaquin.com

Narcotic Linked to Deaths

Cephalon issued a warning letter alerting physicians of recent reports of serious adverse events, including deaths, in patients using fentanyl buccal tablets (Fentora), even though they were not appropriate candidates for this agent. The letter cautions physicians to follow the prescribing recommendations carefully, emphasizing that these deaths appear to be related to improper use in patients who were opioid-intolerant, improper dosing, and/or improper substitution of Fentora for other fentanyl-based medications. Full prescribing information, including a Boxed Warning, is available at www.fentora.com

New Formulations/Dosages

  • Trospium chloride extended release (Sanctura XR; Indevus), a once-daily formulation of this agent, for the treatment of overactive bladder with symptoms of urinary incontinence. www.indevus.com
  • A new 1000-mg dose of ranolazine extended-release tablets (Ranexa; CV Therapeutics), to be initiated at 500 mg twice daily and increased to 1000 mg twice daily, as needed. www.cvt.com
  • A new formulation of fenofibrate (Triglide; LifeCycle Pharma/Sciele Pharma), which enhances absorption and improves bioavailability, in 120-mg and 40-mg dosage strengths, for the treatment of hyperlipidemia and hypertriglyceridemia. www.lcpharma.com
  • A new 250-mg dose of carisoprodol (Soma; MedPointe), which has shown comparable efficacy to the 350-mg dose, for the relief of acute, painful musculoskeletal conditions, such as backache. www.medpointepharma.com

First Generic Carvedilol

The first generic version of the widely used antihypertensive carvedilol (Coreg) has been approved in 4 doses (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg) and will be manufactured by several companies. www.fda.gov/cder/ogd