ClassName/CompanyApproval Dates and Comments

Dermal Filler
Hyaluronic Acid Gel Particles
The US FDA approved this dermal filler in May 2007 for implantation into the deep dermis to superficial subcutis for the correction of moderate-to-severe facial folds and wrinkles, such as nasolabial folds.

Cervical Cancer Vaccine
The Therapeutic Goods Administration of Australia approved this vaccine in May 2007 for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types in females 10 to 45 years of age.

Vaccinia Immune Globulin Intravenous (Human)
The Biologics and Genetic Therapies Directorate of Health Canada approved this vaccine in May 2007 for counteracting certain complications associated with smallpox vaccination.

Levocetirizine Dihydrochloride
UCB/ sanofi-aventis
The US FDA approved this new once-daily prescription antihistamine in May 2007 for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children >6 years of age.

Centocor/ Schering-Plough
The European Commission approved a new indication for this biologic in June 2007 allowing for the treatment of severe, active Crohn’s disease in pediatric patients 6-17 years of age who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies.

Drug News

Warning Letter
The US FDA sent out a warning letter to DUSA Pharmaceuticals in April 2007 about an advertisement for Levulan® Kerastick® for topical solution, stating that it was false or misleading because it presents efficacy claims for this product, but omits and minimizes the risks associated with the use of the drug, broadens the indications and overstates its efficacy. DUSA was instructed to immediately cease the dissemination of this advertising material. They were also asked to submit a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audiences that received the promotional materials.

Focal Dermal Hypoplasia
According to an article published in a recent issue of Nature Genetics*, researchers have identified the gene that accounts for most cases of Goltz syndrome, a rare skin disorder also known as focal dermal hypoplasia, that can also affect bone and eye development. The cases appear to result from a defect in the gene known as PORCN, which is active in the embryo and fetus, creating proteins that are important in the development of the skin, skeleton and eyes. The researchers believe mutations in the PORCN gene cause at least 75% of Goltz syndrome cases.
*Wang X, et al. Nat Genet 39(7):836-8(2007 Jul).