New product newswire

November 7, 2005

Minneapolis-based Upsher-Smith Laboratories, (800) 654-2299, is introducing Vandazole (metronidazole vaginal gel, 0.75%) for the treatment of bacterial vaginosis in nonpregnant patients. According to the company, Vandazole offers an economical alternative to other available metronidazole treatments. It will be manufactured for Upsher-Smith by Teva Pharmaceuticals. The product is available in a 70-gm tube with five applicators.

NEW DRUGS

Minneapolis-based Upsher-Smith Laboratories, (800) 654-2299, is introducing Vandazole (metronidazole vaginal gel, 0.75%) for the treatment of bacterial vaginosis in nonpregnant patients. According to the company, Vandazole offers an economical alternative to other available metronidazole treatments. It will be manufactured for Upsher-Smith by Teva Pharmaceuticals. The product is available in a 70-gm tube with five applicators.

Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000, has FDA approval for Flexbumin (albumin [human]) 25% Solution, which carries the same indications as Baxter's Buminate 25% Solution: hypovolemia and hypoalbuminemia. Buminate, packaged in glass bottles, has been used for more than 50 years in patients undergoing cardiopulmonary bypass surgery and in those suffering from shock, blood loss, and severe burns. According to the company, Flexbumin is the first human albumin preparation to be packaged in a flexible container, providing greater flexibility and less risk of breakage.

An expanded indication has been approved for Abbott Laboratories' Humira (adalimumab). The drug can now be used as first-line treatment of recent-onset moderate to severe rheumatoid arthritis, offering patients critical therapeutic intervention early in the course of RA to help defer crippling joint destruction. Abbott is headquartered in Abbott Park, Ill., at (800) 255-5162.

Pfizer's Aromasin (exemestane tablets) can now be used to treat postmenopausal women with estrogen receptor-positive early breast cancer following two to three years of tamoxifen therapy, for a total of five consecutive years of adjuvant hormonal treatment. Study results have indicated that the combination five-year therapy offers patients 31% more protection from cancer recurrence than five years of tamoxifen therapy. Pfizer Inc., New York City, can be reached at (212) 733-2323.

GlaxoSmithKline, Pittsburgh, (888) 825-5249, has received approval for an expanded use of Havrix (hepatitis A vaccine, inactivated). The drug was previously approved for use in children ages two through 18 years. It is now indicated for the prevention of hepatitis A in children aged 12 months and older.

NOW AVAILABLE

Ambien CR, (zolpidem tartrate extended-release tablets) C-IV, is now available nationwide. The non-narcotic, non-benzodiazepine bi-layered tablet carries an indication for sleep maintenance in addition to sleep induction. The drug is released in two stages, the first to induce sleep and the second, released more gradually, to help provide more continuous sleep. Ambien CR, in contrast to Ambien, is not limited to the short-term treatment of insomnia. The maker is the Sanofi-Aventis Group, Bridgewater, N.J., (908) 243-6000.

NEW PRESENTATION

Follistim AQ (follitropin beta injection), a product of Organon USA, Roseland, N.J., (973) 325-5353, is now available in 75 IU and 150 IU in single-use 0.5-mL vials. The premixed solution eliminates the need for reconstitution, offering patients greater convenience in self-administering the drug. Follistim AQ is indicated for subcutaneous and intramuscular injection for the development of multiple follicles in ovulatory patients undergoing assisted reproductive technology procedures. Follistim AQ is also available in cartridges of 300, 600, and 900 IU.

NEW GENERICS