ClassName/CompanyApproval Dates and Comments

Antiacne Agent
Differin® Gel 0.3%
Galderma Laboratories
The US FDA approved a higher concentration formulation of this topical retinoid in June 2007 for the treatment of moderate-to-moderately severe acne.

Abbott Laboratories
The European Commission granted marketing authorization in June 2007 for the use of this self-administered biologic for the treatment of Crohn’s disease.

Dermal Filler
Hyaluronic Acid Injectable
Soft Tissue Filler
The US FDA approved this soft tissue filler in July 2007 for the treatment of facial wrinkles and scar remediation.

Antifungal Agent
Extina® Foam 2%
Stiefel Laboratories
The US FDA approved this product in July 2007 for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Extina® is administered using VersaFoam® HF® technology, a topical drug delivery vehicle that is quickly absorbed into the skin. Studies show consistent skin permeation, drug distribution, and drug delivery.

Drug News

Treatment for Lupus Nephritis
In June 2007 Aspreva Pharmaceuticals and Roche released preliminary results for a clinical trial comparing oral mycophenolate mofetil (MMF) (CellCept®) with IV cyclophosphamide (IVC), which is the current standard of care for inducing treatment response in the induction phase of patients suffering from lupus nephritis. Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that MMF was superior to IVC in inducing treatment response in this disease. Additional analyses are ongoing to determine the potential for a regulatory submission.

Dermal Fillers
According to an addendum in The Medical Letter*, some consultants for the publication have suggested that their recent article on dermal fillers (Dermal Fillers. Med Lett Drugs Ther 49(1260):39-40 [2007]) should have included stronger warnings about the risk of fillers that are not biodegradable, such as Artefill®. Even with the best technique, the polymethylmethacrylate (PMMA) beads in this product can, over time, cause foreign-body granulomas and hypertrophic scarring, which may require surgical removal. Granulomas and nodules have been especially frequent when Artefill® was injected into the lips. Complications are less likely with hyaluronic acid products such as Hylaform®, Juvederm®, or Restylane®.
*Med Lett Drugs Ther 49(1265):60[2007]