Medicis Announces Approval Of Additional Strengths Of Solodyn(R)

MedicisMedicis announced that FDA has approved additional strengths of SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The Company believes all forms of SOLODYN currently approved for use are covered by its patent rights.

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FDA Warns Of Possible Dangers From Portable Foot-Tanning Device

ultraviolet radiationThe FDA is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device. Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure.

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FDA Approves Adapalene Cream for Acne Vulgaris

E. Fougera & Co has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx) for the treatment of acne vulgaris. Fougera’s Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

Mesynthes Introduces Tissue Substitute

Mesynthes has introduced a tissue substitute for people suffering from tissue damage, burns and reconstructive surgeries. The company’s Endoform Dermal Template is an FDA approved ready-to-use tissue substitute that can be used for wound care and dermal reconstruction. The product will improve the rate and quality of healing. Mesynthes is also developing Endoform Infection Control for the prevention of infection if there is a high risk of post-operative infection.

FDA Study Shows Sunscreens May Increase Skin Cancer Growth

A study done by the FDA indicated that the Vitamin A used in almost half of the roughly 500 sunscreens on the market may actually increase the growth of skin cancer. Dr. Kim Gittere Abson, a dermatologist at the Polyclinic in Seattle, “So this is a study that was conducted by the FDA that looked at mice using a form of Vitamin A called Retinal Palmitate.” “And in the mice, that were just treated with the Vitamin A, versus the ones that were not, there was a 21% increase in skin cancer in those mice.”

Allergan Gets Approval For JUVÉDERM

AllerganAllergan, the pharmaceutical company which manufactures Botox, has received the approval from the US Food and Drug Administration’s (FDA) for its JUVÉDERM® XC. JUVÉDERM XC is a new formulation that contains lidocaine to make the treatment of moderate to severe facial wrinkles and folds much more comfortable.

Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) and ExcellagenFX(TM)

Cardium TherapeuticCardium Therapeutic has announced that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company’s recently completed Phase 2b Matrix clinical study. ExcellagenXL(TM) and ExcellagenFX(TM) are advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds.

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FDA recommendation on indoor tanning going unheeded

SDSUThe FDA has recommended but has not made it a requirement for indoor tanning bed operators to limit teens to three or fewer tanning bed sessions in the first week. Researchers from San Diego State University and colleagues have indicated that only about 11% indoor tanning bed operators did so, and 71% of tanning bed operators said they would allow a teen to tan seven days a week.

FDA gives nod to Solta Medical for aesthetic laser device

SoltaMedicalSolta Medical Inc has received approval from the FDA of a new version of its popular Fraxel re:store Dual Laser System to clear pigmentation and other superficial skin conditions. The device with a 1550 nanometer (nm) wavelength already has the regulatory approval for skin resurfacing and treatment of pigmented lesions and certain other skin conditions.

FDA committees recommend approval of reformulated OxyContin

PurdueTwo FDA advisory committees voted in favor of the approval of Purdue Pharma’s reformulated version of long-acting OxyContin, despite some members’ concerns over the drug’s safety. The OxyContin drug designed to be abuse-deterrent. The reformulated version of OxyContin (oxycodone HCl) would be slightly safer than the current product, although its safety profile for the majority of users is still doubtful, according to David Margolis, the professor of dermatology and epidemiology at the University of Pennsylvania.

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