Blog Archives

Sales of HydroPeptide soaring

hydropeptideHydroPeptide Lash Longer Fuller Lusher is rapidly gaining popularity in the US as the new lash product due to its drug-free formulation and impressive results. HydroPeptide Lash’s popularity is partly due to the fact that the product does not contain “glaucoma type meds” like Latisse®, Peter Thomas Roth Lashes To Die for, Lilash or MD Lash Factor. The FDA is taking action against the other products because the “use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.”

SOLODYN approved in additional strengths

SolodynThe 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

sculptraThe 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

sanofiThe 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-approved wrinkle treatment hits US market

DysportThe FDA has recently approved a new injectable treatment for wrinkles, called Dysport. A local doctor said it is less expensive, works faster and could last longer than Botox. “It is a botulism product just like Botox,” said plastic surgeon Brian Heil. Dysport is used to relax scowl lines on the face. It has been in use in Europe for years, but the new FDA approval is opening the door for Dysport in the US.

Better Body Solutions launches painless alternative to liposuction

Innovative healthcare center, Better Body Solutions, has launched a non-surgical sculpting treatment called Body Lite Laser Treatment. This treatment reduces fat without the pain or downtime associated with liposuction. A “lunchtime” procedure, it consists of several 40-minute treatments over a period of one to three weeks and uses the Zerona laser, which was the recently studied by the FDA and proved safe and effective for emulsifying fat cells from patients’ target areas without side effects.

FDA approves New Acne Treatment

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.

FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections

Johnson & Johnson Pharmaceutical Research & Development has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

FDA clearance to Reliant Technologies’ new hand pieces

The U.S. Food and Drug Administration has given 510(k) clearance to Reliant Technologies Inc. for three novel Fraxel re:pair laser hand pieces. This enhanced potential of the Fraxel re:pair laser system will provide physicians with an option for surgical treatment and skin resurfacing. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all of the three surgical hand pieces can be used alone or along with each other, with no need to turn the system off for changing the hand pieces.

Photocure’s Metvixia gets safety labeling revision from FDA

The U.S. Food and Drug Administration has approved safety labeling revisions for Photocure’s Metvixia (methyl aminolevulinate HCl 16.8%) for use with the company’s Aktilite CL238 lamp. The site of treatment becomes photosensitive during the period between application of the cream and red-light illumination. That is why FDA has warned of adverse effects of dermal photosensitization, advising patients to avoid exposing the area to bright light. Sunscreen does not help in the protection of treated lesions. Patients should stay away from sunlight for two days after the therapy. FDA has also laid down that only trained physicians can apply the Metvixia cream.

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