Product News: 07 2014

CoolSculptingZeltiq Aesthetics, Inc, introduces the CoolSmooth applicator and obtains US Food and Drug Administration clearance for the CoolSculpting procedure to treat the thigh area. The CoolSmooth applicator is designed for fat reduction of the outer thigh. It is a flat applicator that features nonvacuum-based cooling to easily treat nonpinchable fat bulges, offering physicians the ability to optimize patient outcomes and expand CoolSculpting treatment areas. The CoolSculpting procedure previously was cleared for noninvasive fat reduction in the abdomen and flank; now the thigh area (inner and outer thighs) can be treated with the entire suite of applicators. For more information, visit www.coolsculpting.com.

DalvanceDurata Therapeutics, Inc, obtains US Food and Drug Administration approval for Dalvance (dalbavan-cin), an intravenous antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and Streptococcus pyogenes. Dalvance is a second-generation semisynthetic lipoglycopeptide. It is administered in a 2-dose regimen of 1000 mg followed 1 week later by 500 mg. Each dose is administered over 30 minutes. Dalvance provides physicians with a treatment option that moves beyond the standard daily or twice-daily intravenous antibiotic infusions. Exercise caution in patients with known hypersensitivity to glycopeptides. For more information, visit www.dalvance.com.

excel HR Laser SystemCutera, Inc, introduces the excel HR laser system for hair removal. excel HR is a dual-wavelength laser system that combines the high-power 755-nm alexandrite and the 1064-nm Nd:YAG with sapphire contact cooling to effectively target deep follicular structures and deliver energy more efficiently. The result is enhanced efficacy using less fluence with improved patient comfort. excel HR has received 510(k) clearance by the US Food and Drug Administration. For more information, visit www.cutera.com/excelhr.

JubliaValeant Pharmaceuticals International, Inc, obtains US Food and Drug Administration approval for Jublia (efinaconazole solution 10%) for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. This quick-drying solution is applied daily to the nail with a bottle that has a built-in flow-through brush applicator. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury. For more information, visit www.jubliarx.com.

SitavigInnocutis launches Sitavig (acyclovir) 50-mg buccal tablets for herpes labialis in the United States. Sitavig uses a proprietary Lauriad delivery system that consists of a tablet that sticks to the patient’s gum, above the canine tooth on the side of the lip that is infected with a cold sore, then dissolves to provide sustained release of medicine. The tablet is tasteless and odorless. Sitavig is user-friendly; patients can eat and drink normally once the tablet adheres to the gum, usually within a few minutes. The application once per episode is unique compared to other systemic and topical treatments. Sitavig is licensed from BioAlliance Pharma. For more information, visit www.innocutis.com.

SivextroCubist Pharmaceuticals announces US Food and Drug Administration approval of Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections in adults caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. It is available as an intravenous infusion over 1 hour or as a 200-mg tablet administered once daily. Both methods offer an effective 6-day course of therapy. Sivextro allows physicians to transition patients from intravenous to oral treatment; oral administration provides the opportunity for outpatient care. For more information, visit www.sivextro.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].

CoolSculptingZeltiq Aesthetics, Inc, introduces the CoolSmooth applicator and obtains US Food and Drug Administration clearance for the CoolSculpting procedure to treat the thigh area. The CoolSmooth applicator is designed for fat reduction of the outer thigh. It is a flat applicator that features nonvacuum-based cooling to easily treat nonpinchable fat bulges, offering physicians the ability to optimize patient outcomes and expand CoolSculpting treatment areas. The CoolSculpting procedure previously was cleared for noninvasive fat reduction in the abdomen and flank; now the thigh area (inner and outer thighs) can be treated with the entire suite of applicators. For more information, visit www.coolsculpting.com.

DalvanceDurata Therapeutics, Inc, obtains US Food and Drug Administration approval for Dalvance (dalbavan-cin), an intravenous antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and Streptococcus pyogenes. Dalvance is a second-generation semisynthetic lipoglycopeptide. It is administered in a 2-dose regimen of 1000 mg followed 1 week later by 500 mg. Each dose is administered over 30 minutes. Dalvance provides physicians with a treatment option that moves beyond the standard daily or twice-daily intravenous antibiotic infusions. Exercise caution in patients with known hypersensitivity to glycopeptides. For more information, visit www.dalvance.com.

excel HR Laser SystemCutera, Inc, introduces the excel HR laser system for hair removal. excel HR is a dual-wavelength laser system that combines the high-power 755-nm alexandrite and the 1064-nm Nd:YAG with sapphire contact cooling to effectively target deep follicular structures and deliver energy more efficiently. The result is enhanced efficacy using less fluence with improved patient comfort. excel HR has received 510(k) clearance by the US Food and Drug Administration. For more information, visit www.cutera.com/excelhr.

JubliaValeant Pharmaceuticals International, Inc, obtains US Food and Drug Administration approval for Jublia (efinaconazole solution 10%) for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. This quick-drying solution is applied daily to the nail with a bottle that has a built-in flow-through brush applicator. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury. For more information, visit www.jubliarx.com.

SitavigInnocutis launches Sitavig (acyclovir) 50-mg buccal tablets for herpes labialis in the United States. Sitavig uses a proprietary Lauriad delivery system that consists of a tablet that sticks to the patient’s gum, above the canine tooth on the side of the lip that is infected with a cold sore, then dissolves to provide sustained release of medicine. The tablet is tasteless and odorless. Sitavig is user-friendly; patients can eat and drink normally once the tablet adheres to the gum, usually within a few minutes. The application once per episode is unique compared to other systemic and topical treatments. Sitavig is licensed from BioAlliance Pharma. For more information, visit www.innocutis.com.

SivextroCubist Pharmaceuticals announces US Food and Drug Administration approval of Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections in adults caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. It is available as an intravenous infusion over 1 hour or as a 200-mg tablet administered once daily. Both methods offer an effective 6-day course of therapy. Sivextro allows physicians to transition patients from intravenous to oral treatment; oral administration provides the opportunity for outpatient care. For more information, visit www.sivextro.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].

CoolSculptingZeltiq Aesthetics, Inc, introduces the CoolSmooth applicator and obtains US Food and Drug Administration clearance for the CoolSculpting procedure to treat the thigh area. The CoolSmooth applicator is designed for fat reduction of the outer thigh. It is a flat applicator that features nonvacuum-based cooling to easily treat nonpinchable fat bulges, offering physicians the ability to optimize patient outcomes and expand CoolSculpting treatment areas. The CoolSculpting procedure previously was cleared for noninvasive fat reduction in the abdomen and flank; now the thigh area (inner and outer thighs) can be treated with the entire suite of applicators. For more information, visit www.coolsculpting.com.

DalvanceDurata Therapeutics, Inc, obtains US Food and Drug Administration approval for Dalvance (dalbavan-cin), an intravenous antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and Streptococcus pyogenes. Dalvance is a second-generation semisynthetic lipoglycopeptide. It is administered in a 2-dose regimen of 1000 mg followed 1 week later by 500 mg. Each dose is administered over 30 minutes. Dalvance provides physicians with a treatment option that moves beyond the standard daily or twice-daily intravenous antibiotic infusions. Exercise caution in patients with known hypersensitivity to glycopeptides. For more information, visit www.dalvance.com.

excel HR Laser SystemCutera, Inc, introduces the excel HR laser system for hair removal. excel HR is a dual-wavelength laser system that combines the high-power 755-nm alexandrite and the 1064-nm Nd:YAG with sapphire contact cooling to effectively target deep follicular structures and deliver energy more efficiently. The result is enhanced efficacy using less fluence with improved patient comfort. excel HR has received 510(k) clearance by the US Food and Drug Administration. For more information, visit www.cutera.com/excelhr.

JubliaValeant Pharmaceuticals International, Inc, obtains US Food and Drug Administration approval for Jublia (efinaconazole solution 10%) for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. This quick-drying solution is applied daily to the nail with a bottle that has a built-in flow-through brush applicator. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury. For more information, visit www.jubliarx.com.

SitavigInnocutis launches Sitavig (acyclovir) 50-mg buccal tablets for herpes labialis in the United States. Sitavig uses a proprietary Lauriad delivery system that consists of a tablet that sticks to the patient’s gum, above the canine tooth on the side of the lip that is infected with a cold sore, then dissolves to provide sustained release of medicine. The tablet is tasteless and odorless. Sitavig is user-friendly; patients can eat and drink normally once the tablet adheres to the gum, usually within a few minutes. The application once per episode is unique compared to other systemic and topical treatments. Sitavig is licensed from BioAlliance Pharma. For more information, visit www.innocutis.com.

SivextroCubist Pharmaceuticals announces US Food and Drug Administration approval of Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections in adults caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. It is available as an intravenous infusion over 1 hour or as a 200-mg tablet administered once daily. Both methods offer an effective 6-day course of therapy. Sivextro allows physicians to transition patients from intravenous to oral treatment; oral administration provides the opportunity for outpatient care. For more information, visit www.sivextro.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].