UPDATE ON DRUGS
|Class||Name/Company||Approval Dates and Comments|
|The US FDA approved these reformulated 2.5mg and 5mg tablets in July|
2005 for the treatment of allergy symptoms caused by both perennial indoor
and seasonal outdoor allergens, and chronic idiopathic urticaria, or hives of
unknown cause in adults and children >6 years of age. This formulation
dissolves without water.
ACZONE™ Gel 5%
|The US FDA approved this topical gen in July 2005 for the treatment|
of acne vluaris.
Metrogel® Topical Gel 1%
|The US FDA approved this topical product in July 2005 for the|
treatment of inflammatory lesions of rosacea.
|Measles, Mumps, Rubella and Varicella Vaccine|
|The US FDA approved this live attenuated viral vaccine in September|
2005 for simultaneous vaccination against measles, mumps, rubella,
and varicella in children 12 months to 12 years of age. Also in
September 2005, the Committee for Medicinal Products for Human
Use adopted a positive opinion and recommended that marketing
authorization be granted in Europe.
Hypertrichosis and Hirsutism
|Barrier Therapeutics announced in June 2005 that it has acquired the right to distribute VANIQA®|
(eflornithine) 13.9% cream in Canada from Shire Pharmaceuticals. Marketing is expected to begin in
October 2005. VANIQA® is approved by Health Canada for slowing the growth of unwanted facial hair in
women by blocking an enzyme that is necessary for hair growth during the growth phase of the hair cycle.
Clinical trials have shown positive results after 4-8 weeks of use with continued improvement over time.
|According to a case study in the New England Journal of Medicine*, a 62-year-old woman had|
progression of multiple myeloma despite many therapies, including an autologous hematopoietic stem-cell
transplantation. Infusions of bortezomib (1.3mg/m2 of body surface area) were administered as an IV bolus
twice weekly for 2 weeks, followed by a 10-day rest period. During the second treatment cycle, a purpuric
rash, not associated with fever or itching, developed on the patient’s trunk, back, hands and face. Biopsy of
the skin lesion revealed a leukocytoclastic vasculitis. The patient was treated with 20mg prednisone, and
the rash resolved. The rash recurred with subsequent cycles of bortezomib treatment.
*N Engl J Med 352(24):2534 (2005 Jun 16).
|In one of the largest adult vaccine clinical trials ever, researchers have found that an experimental vaccine|
against shingles (ZOSTAVAX™, Merck) reduced the incidence of shingles by 51% and dramatically
reduced its severity and complications in vaccinated persons who got the disease. The randomized, doubleblind,
placebo controlled trial was conducted at 22 study sites throughout the US with 38,500 men and
women aged >60 years in order to determine whether vaccination with a single dose of this live attenuated
vaccine would reduce the incidence and/or severity of shingles.*
*N Engl J Med 352(22):2271-84 (2005 Jun 2).