October 2012 | Volume 11 | Issue 10 | Feature | 1249 | Copyright © 2012
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
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Watson's Generic Lidoderm® Receives FDA Approval
Watson Laboratories, Inc., a subsidiary of Watson Pharmaceuticals, Inc. has announced that it has received final approval from the FDA on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm®. The product had been the subject of patent litigation, but a settlement was reached that will allow Watson to launch the product in September of 2013.
On May 29, 2012, Watson announced it had entered into an agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd to settle all outstanding patent litigation related to Watson's generic version of Lidoderm. The agreement allows Watson to launch its lidocaine topical patch 5% product on September 15, 2013.
For the twelve months ending June 30, 2012, Lidoderm had total U.S. sales of approximately $1.2 billion according to IMS Health data.
MiraDry® is FDA Approved for Sweating
The Austin-Weston Center for Cosmetic Surgery, a freestanding center established exclusively for cosmetic surgery in the Washington, D.C. area has introduced MiraDry®, an FDA-approved, non-invasive, lasting treatment for excessive underarm sweating. Standard treatment for patients with extreme underarm sweating has been regular Botox injections, repeated every 6 to 9 months, to the underarms to temporarily disable the sweat glands, or surgery. MiraDry seems to take two, at most, non-invasive treatments to stop excessive underarm sweating, and appears to be permanent. The procedure takes approximately an hour.
MiraDry utilizes a microwave energy that eliminates the eccrine gland, commonly known as the sweat gland. Because sweat glands do not regenerate, the results are immediate and permanent. In addition, the apocrine, or odor, glands, which reside in proximity to the sweat glands in the underarm area, are often eliminated as well during the procedure.
Palomar Vectus Laser for Laser Hair Removal
Palomar Medical Technologies, Inc. has announced the launch of the Palomar Vectus™ Laser, a dedicated solution for highvolume hair removal. It provides fast, uniform, permanent hair reduction for the widest range of skin and hair types without sacrificing comfort. The Palomar Vectus Laser features an integrated Skintel™ Melanin Reader, allowing providers to more safely offer laser hair removal treatments with optimized outcomes tailored to each client's skin type, sun exposure habits, and ethnicity. Additionally, the Palomar Vectus Laser uses an intelligent user interface, which allows the provider to quickly select treatment parameters based on the client's hair density, hair color, hair diameter, and Fitzpatrick Skin Type or Skintel Value. Its large spot size allows treatment of male backs or female legs within 20 minutes, and its parameters are optimized for minimizing patient discomfort.
Skin Product Approved for Diabetic Foot Ulcers
Shire Regenerative Medicine has announced that its human fibroblast-derived dermal substitute Dermagraft has been approved by Health Canada as a class-4 medical device for the treatment of diabetic foot ulcers. The product is currently available in the United States, where it received approval as a class 3 medical device in September 2001 and will be available in Canada in the first quarter of 2013.
The dermal substitute is manufactured from human fibroblast cells derived from newborn foreskin tissue. The product is indicated for use in the treatment of full-thickness diabetic foot ulcers with greater than 6 weeks' duration, which extend through the dermis but do not have tendon, muscle, joint capsule, or bone exposure.
Shire Regenerative Medicine states that during the manufacturing process, the human fibroblasts are seeded onto a bioresorbable scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells.
NovaBay Receives FDA clearance for NeutroPhase
NovaBay Pharmaceuticals has announced that it has received 510(k) clearance from the FDA to market its NeutroPhase skin and wound cleanser under widened indications, including the moistening and debriding of graft and donor sites. The FDA also cleared NeutroPhase to be administered through a new spray pump.