Aesthetics Product Guide » FDA Approval

FDA Warns Of Possible Dangers From Portable Foot-Tanning Device

admin — Mon, 30 Aug 2010 09:58:44 +0000

The 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

admin — Wed, 07 Jul 2010 19:00:30 +0000

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.

Allergan Gets Approval For JUVÉDERM

admin — Tue, 02 Feb 2010 05:08:34 +0000

Allergan, 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.

FDA recommendation on indoor tanning going unheeded

admin — Mon, 26 Oct 2009 15:50:23 +0000

The 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

admin — Mon, 19 Oct 2009 14:40:55 +0000

Solta 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

admin — Mon, 05 Oct 2009 06:54:20 +0000

Two 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.

SOLODYN approved in additional strengths

admin — Mon, 07 Sep 2009 08:39:25 +0000

The FDA has approved additional strengths of Medicis’ SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 12 years and more. The drug will now be available in 65mg and 115mg dosages also. “These additional strengths will complement the current SOLODYN lineup to offer physicians more precise weight-based dosing options, and make SOLODYN the first and only extended release minocycline with five FDA-approved dosing strengths. We believe physicians and patients will appreciate the value of this greater dosing precision,” Jonah Shacknai, Chairman and Chief Executive Officer of Medicis said.

Anti-wrinkle product SculptraAesthetic approved

admin — Mon, 24 Aug 2009 06:34:43 +0000

The FDA has approved Sanofi-aventis US’ anti-wrinkle product SculptraAesthetic for the correction of shallow to deep nasolabial fold, also called smile lines, contour deficiencies and other facial wrinkles with the appropriate injection technique in healthy patients. SculptraAesthetic works gradually to offer natural-looking results that can last up to two years.

FDA approves long acting facial filler

admin — Mon, 17 Aug 2009 11:54:55 +0000

The FDA has approved the use of Sculptra Aesthetic long acting facial filler that builds collagen. Sculptra Aesthetic (injectable poly-L-lactic acid) has been approved for use by a trained physician to correct shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles. The injectable dermal filler works gradually to offer natural-looking results that can last up to two years. The treatment was available in Europe for a decade.

FDA approves New Acne Treatment

admin — Mon, 06 Jul 2009 08:01:28 +0000

A new prescription acne gel called Epiduo has been approved by the FDA for patients aged 12 and more. Epiduo is the combination of two drugs, benzoyl peroxide 2.5% and adapalene 0.1%, which are being used as acne treatments since long. Epiduo, manufactured by Galderma, is the once daily drug and is the “first and only” combination acne gel of its kind.