FDA Approvals & NewsPerlane Dermal Filler Approved The FDA has approved the hyaluronic acid-based filler Perlane for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane joins Restylane in Medicis’s family of products. Although both Perlane and Restylane are hyaluronic acid-based fillers, the primary difference between them is that the hyaluronic acid gel particles in Perlane are larger than those in Restylane, and Perlane is intended for implantation into the deep dermis to superficial layer of the subcutis to add volume to restore surface contour in facial wrinkles and folds. With effects lasting for about 6 months, both Perlane and Restylane are minimally cross-linked, making them similar to the natural hyaluronic acid found in the body. New Prescribing Information for Solagé ApprovedThe FDA has approved Barrier Therapeutics’ application to add clinical data to the prescribing information for mequinol 2%, tretinoin 0.01% (Solagé Topical Solution). According to Barrier Therapeutics, Solagé Topical Solution is the only FDA-approved combination skin lightening agent that does not contain hydroquinone. The newly added information focuses on the safety and efficacy of Solagé in patients with darker skin types.Based on a Phase IV post-approval study, the new prescribing information reports on data that demonstrated favorable results in the treatment of solar lentigines in African American, Asian and Latin/Hispanic patients. More than 80% of treated patients in this study achieved a significant response to therapy for facial and arm lesions. Study participants also maintained the positive clinical results during a 4-week post-treatment period. These results are consistent with efficacy findings previously reported for Caucasian individuals.Alma Laser Receives FDA ClearanceAlma Lasers has received clearance from the FDA to market the Accent Dual Mode RF System in the United States.Receiving its first FDA indication for the treatment of wrinkles and rhytids, the Accent system has been successfully used by medical professionals worldwide to treat a variety of dermatological and aesthetic conditions.This non-invasive and non-ablative system combines two radiofrequency modes into one device. Each mode is delivered by a handpiece that enables volumetric RF thermotherapy at different tissue depths within the body. Boxed Warning for MRI Contrast AgentAll gadolinium-based contrast agents, which are used to enhance the quality of magnetic resonance imaging (MRI), must now carry a boxed warning, according to the FDA.Contrast agents containing gadolinium have been linked to a rare and potentially fatal disease known as nephrogenic systemic fibrosis (NSF), a disease of unknown cause that results in thickening of both the skin and connective tissues, which inhibits patients’ ability to move and may result in broken bones. The disease occurs in patients who have a combination of kidney failure and acidosis and it has no known consistently effective treatment. No reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency have emerged.In June of last year, at least 25 cases of patients who had kidney failure and who had received a gadolinium-based contrast agent in high doses emerged.The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating and potentially fatal disease. In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.In the United States, five gadolinium-based contrast agents have been approved. These include: gadopentetate dimeglumine (Magnevist), gadodiamide (Ominiscan); gadoversetamide (OptiMARK); gadobenate dimeglumine (MultiHance); (gadobenate dimeglumine); and gadoteridol (Prohance).For more information, see www.fda.gov/cder/drug/infopage/gcca/default.htm. New Formulation of Isotretinoin ApprovedThe FDA has sent an approvable letter to Cipher Pharmaceuticals for its NDA for CIP Isotretinoin for the treatment of severe acne. CIP Isotretinoin is based on the company’s patented Lidose drug delivery system, which incorporates active ingredients in semi-solid or liquid compositions inside capsules. This delivery system, according to Cipher Pharmaceuticals, “facilitates low manufacturing costs while delivering super-bioavailability for relatively water-insoluble compounds.”According to the FDA, CIP Isotretinoin is approvable after two remaining issues have been resolved. These issues pertain to a question related to chemistry, manufacturing and controls, and the other is a request for more clinical data. The company stated it would appeal the latter request.