Name/CompanyApproval Dates and Comments

Poly-ureaurethane 16% nail solution

Innocutis Medical

The US FDA approved a poly-ureaurethane 16% nail solution in September 2012 for the management of fragile, damaged or brittle nails with cracking or splitting (referred to as nail dystrophy). Among the most common forms of nail dystrophy is brittle nail syndrome, which affects about 20% of the general population. Symptoms include painful nails that can interfere with daily activities (e.g., negatively impact occupational abilities). This novel formulation mechanically supports the damaged nail plate using a proprietary polymer blend that creates a strong adhesion to the nail surface, forming a barrier that protects from further injury and strengthens the nail.

Calcipotriene 0.005% foam

Stiefel, a GSK Company

The FDA approved a supplemental New Drug Application (sNDA) in September 2012 for calcipotriene foam 0.005%. Approval of this sNDA expands the sanctioned uses to include the topical treatment of plaque psoriasis of the scalp. With these recent changes, this topical synthetic vitamin D3 analog is now indicated for the treatment of plaque psoriasis of the scalp and body in patients >18 years of age.

Hyaluronic acid injectable gel

Medicis Aesthetics, Inc.

The FDA granted an additional indication in August 2012 to this transparent hyaluronic acid gel dermal filler. The expanded indication includes submucosal implantation for lip augmentation in patients >21 years of age. Restylane-L® is also approved for injection into facial tissue to smooth wrinkles and folds (e.g., nasolabial). The gel temporarily adds volume to the skin and can give the appearance of a fuller lip or a smoother surface. This formulation contains 0.3% lidocaine, a topical anesthetic intended to reduce pain experienced by patients during the procedure.

Drug News

In September 2012, the FDA issued a warning letter to Lancôme USA, a unit of L’Oréal SA, regarding the marketing of certain anti-wrinkle products, saying the products are promoted with claims and language suggestive of drugs. The letter specifically cited examples from the manufacturer’s website, including Lancôme’s Génifique Youth Activating Concentrate, Génifique Eye Youth Activating Eye Concentrate, and Génifique Cream Serum Youth Activating Cream Serum with the claim Boosts the activity of genes and stimulates the production of youth proteins; Génifique Repair Youth Activating Night Cream Boosts the activity of genes; and Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream and Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream claim to contain A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation – has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality. The FDA states any product that is intended to affect the structure or function of the human body is classified as a drug and companies are prohibited from the sale of such products in the US without submitting an application to the agency proving safety and efficacy prior to being granted marketing approval. The current wording of the claims promotes therapeutic properties that cause the cosmeceutical products to be considered as drugs, therefore violating the Federal Food, Drug, and Cosmetic Act.