New product newswire

June 6, 2005

From GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, comes Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap]). The product is indicated as a booster vaccine to be given as a single dose to patients aged 10 to 18. This booster adds a pertussis component to the tetanus/diphtheria booster routinely administered to teens.

NEW DRUGS From GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, comes Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap]). The product is indicated as a booster vaccine to be given as a single dose to patients aged 10 to 18. This booster adds a pertussis component to the tetanus/diphtheria booster routinely administered to teens.

Gammagard Liquid (immune globulin intravenous [human]) 10% Solution has been approved for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. The condition is a group of genetic disorders in which the immune system fails to produce adequate amounts of antibodies, placing individuals at increased risk of infection. The sterile preparation, which requires no reconstitution, is a product of Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000.

Cangene Corp., Winnipeg, Canada, (204) 275-4178, holds FDA approval for its Vaccinia Immune Globulin (VIG) Intravenous (Human) for the treatment and prevention of severe adverse reactions associated with smallpox vaccine. VIG, also known as a hyperimmune product, is a highly purified specialty antibody derived from human plasma. It was developed under a contract with the CDC as part of the government's smallpox vaccination program.

Treatment for chronic hepatitis B, which can lead to cirrhosis, hepatocellular carcinoma, and death, has been approved as a new indication for Pegasys (peginterferon alfa-2a). The pegylated interferon, which targets both the HbeAg-positive and -negative variations of the virus, is taken for a fixed duration of 48 weeks, with the goal of a lasting response upon the completion of treatment. Pegasys was approved earlier to treat hepatitis C. The maker is Hoffmann-La Roche, Nutley, N.J., (973) 235-5000.

Prometheus Laboratories, San Diego, (888) 423-5227, has approval for an additional indication for Entocort EC (budesonide) Capsules. The medication can now be used for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to three months. The oral formulation of this topical glucocorticosteroid allows for local release internally to enhance symptom control.

Zofran (ondansetron hydrochloride) Injection, an antiemetic approved earlier for preventing both postoperative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV) in patients as young as two years of age, can now be used for the prevention of PONV in children as young as one month of age and CINV in children as young as six months. Zofran is manufactured by GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100.

A new indication for Hyzaar (losartan potassium/ hydrochlorothiazide) has been cleared for Merck & Co., Whitehouse Station, N.J., (908) 423-1000. The medication, an angiotensin II receptor blocker/diuretic combination, previously approved for hypertension, is now cleared for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy.

There is a new treatment option for the pain of endometriosis in women. From Pfizer Inc., New York City, (212) 733-2323, Depo-subQ Provera 104 is a long-acting injectable contraceptive and a new formulation of medroxyprogesterone acetate, the same active ingredient as used in the previously approved Depo Provera Contraceptive Injection. The new formulation is injected four times a year to halt menstruation, resulting in thinner endometrial tissue. Depo-subQ Provera 104 was approved in December 2004 as a contraceptive for injection every three months. One potential side effect of the drug is significant bone loss.