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Update on Drugs and Drug News: February 2012


Name/Company Approval Dates and Comments

Adapalene 0.1% + benzoyl peroxide 2.5% gel
Epiduo®
Galderma Laboratories, L.P.

The US FDA approved a pump dispenser in December 2011 for this fixed combination of adapalene and benzoyl peroxide formulation for the topical treatment of acne vulgaris in patients ≥12 years of age. A randomized survey study reported that patients found the pump dispenser to be more convenient and easier to use compared with the tube. More than 90% of surveyed patients found the pump to deliver a consistent amount of the gel for application, thereby saving time during treatment administration.

Hyaluronic acid-based dermal filler
Belotero® Balance
Merz Aesthetics, Inc. Anteis S.A.

The US FDA approved this hyaluronic acid-based cohesive gel dermal filler in November 2011 for the temporary correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The advantages of this monophasic filler with cohesive polydensified matrix technology include immediate and long-lasting effects, minimal pain or discomfort during injection into the dermis, and higher viscosity and elasticity, resulting in smoother integration.

Drospirenone 3 mg + ethinyl estradiol 0.02 mg
Vestura™
Watson Pharmaceuticals Inc.

The US FDA granted marketing approval in November 2011 to this generic version of Bayer’s Yaz® oral contraceptive product, which is indicated for the prevention of pregnancy and for the treatment of moderate acne in women ≥14 years of age, but only if the patient desires an oral contraceptive for birth control.


Device & Diagnostic News

In 2011, following initial Health Canada approval in October and CE Marking certification for Europe in November, the Therapeutic Goods Association of Australia granted marketing approval in December to Verisante Aura™ (Verisante Technology, Inc.), a laser Raman spectroscopy system that aids in the assessment of suspect skin lesions for diagnosis as either skin cancer or benign cutaneous disorders in less than 2 seconds. The device uses Raman spectroscopy to biochemically analyze the skin and automate the diagnostic process, allowing rapid scanning of 20-40 skin lesions on at-risk individuals. This optical system is indicated for use in the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma and/or basal cell carcinoma when a medical professional chooses to obtain additional information to rule out one of the above conditions before making a final decision to biopsy. The process to gain US FDA approval was initiated in late December 2011.
More information is available at: http://verisante.com/news/70/verisante-obtains-australian-approval/

In November 2011, the US FDA issued an Approvable Letter for MelaFind® (MELA Sciences, Inc.),1 an optical imaging and analysis device used in the detection of melanoma, comprised of a multispectral digital dermoscope with special system software that performs the image processing sequence. It captures, displays, and stores multispectral (from blue to near infrared) and reconstructed digital images of clinically atypical pigmented skin lesions, and uses automatic image analysis and statistical pattern recognition to differentiate between early melanoma and benign atypical neoplasms.2 MelaFind® is intended to be used when a dermatologist chooses to acquire additional information for a decision to biopsy. CE Marking certification for the European Union was granted in September 2011.
More information is available at:
  1. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm280864.htm
  2. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM233837.pdf

  1. Ingenol Mebutate: An Introduction
  2. Laser Management of Acne Scarring
  3. Skin Treatments Introduced in 2011
  4. Diagnostics and Devices Introduced in 2011
  5. Update on Drugs and Drug News - February 2012
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