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Avène TriXera
Pierre Fabre Dermo-Cosmetique launches the Avène TriXera line consisting of 3 products. The TriXera Nutrition Nutri-fluid Cleanser gently cleanses and nourishes dry to very dry, sensitive skin. TriXera Nutrition Nutri-fluid Lotion offers 48-hour hydration for dry, sensitive skin. These nourishing effects last up to 6 hours after application. TriXera Nutrition Nutri-fluid Balm has a fluidlike texture and also offers 48-hour hydration. All 3 products contain Avène Thermal Spring Water to soothe and soften as it restores the skin’s balance, as well as evening primrose oil and soy extract to rebuild the skin barrier and prevent moisture loss. For more information, visit www.aveneusa.com.
CoolSculpting
Allergan plc announces US Food and Drug Administration clearance for the CoolSculpting treatment, a nonsurgical fat reduction technology for improved appearance of lax tissue in conjunction with submental fat. CoolSculpting works by gently cooling targeted fat cells in the body to induce natural, controlled elimination of fat cells without affecting surrounding tissue. For more information, visit www.coolsculpting.com.
Discoloration Defense
SkinCeuticals introduces Discoloration Defense, a high-potency treatment serum that prevents and corrects multiple types of discoloration. This product contains tranexamic acid and niacinamide for pigmentation, hepes for hydration, and kojic acid to brighten skin and help to reduce the amount of melanin produced. These ingredients work together to help break up existing melanin clusters, inhibit the formation of melanocytes, and deactivate inflammatory mediators. The serum provides a reduction in visible and stubborn pigmentation for a revitalized and even complexion with refined texture and clarity. For more information, visit www.skinceuticals.com.
Eskata
Aclaris Therapeutics, Inc, announces US Food and Drug Administration approval of Eskata (hydrogen peroxide) topical solution 40% for the treatment of raised seborrheic keratoses. This product is a targeted, in-office treatment applied directly to raised seborrheic keratoses using a penlike applicator. Clinical studies showed clearing of seborrheic keratoses after 2 treatments. Eskata is expected to be commercially available in the spring of 2018. For more information, visit www.eskata.com.
Ixifi
Pfizer Inc announces US Food and Drug Administration approval of Ixifi (infliximab-qbtx), a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product. Ixifi has been approved in the United States as a treatment for rheumatoid arthritis, Crohn disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. For more information, visit www.pfizer.com.
Jemdel
Ortho Dermatologics announces US Food and Drug Administration acceptance of the New Drug Application for Jemdel (halobetasol propionate 0.01%), a high-potency topical steroid for the treatment of plaque psoriasis with dosing for as long as 8 weeks. Jemdel has a Prescription Drug User Fee Act action date of October 5, 2018. For more information, visit www.ortho-dermatologics.com.
Retin-A Micro
Ortho Dermatologics announces that Retin-A Micro (tretinoin) gel microsphere 0.06%, a topical treatment for acne vulgaris, will be available commercially to health care professionals. The US Food and Drug Administration previously approved the Supplemental New Drug Application for this product in October 2017. Retin-A Micro features a microsponge delivery system technology that helps control the release of tretinoin and improves photostability, even when used in conjunction with benzoyl peroxide. This product also features a pump delivery system for controlled dispensing and consistent dosing. Caution should be exercised when prescribing to eczema patients and nursing mothers. For more information, visit www.retinamicro.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Avène TriXera
Pierre Fabre Dermo-Cosmetique launches the Avène TriXera line consisting of 3 products. The TriXera Nutrition Nutri-fluid Cleanser gently cleanses and nourishes dry to very dry, sensitive skin. TriXera Nutrition Nutri-fluid Lotion offers 48-hour hydration for dry, sensitive skin. These nourishing effects last up to 6 hours after application. TriXera Nutrition Nutri-fluid Balm has a fluidlike texture and also offers 48-hour hydration. All 3 products contain Avène Thermal Spring Water to soothe and soften as it restores the skin’s balance, as well as evening primrose oil and soy extract to rebuild the skin barrier and prevent moisture loss. For more information, visit www.aveneusa.com.
CoolSculpting
Allergan plc announces US Food and Drug Administration clearance for the CoolSculpting treatment, a nonsurgical fat reduction technology for improved appearance of lax tissue in conjunction with submental fat. CoolSculpting works by gently cooling targeted fat cells in the body to induce natural, controlled elimination of fat cells without affecting surrounding tissue. For more information, visit www.coolsculpting.com.
Discoloration Defense
SkinCeuticals introduces Discoloration Defense, a high-potency treatment serum that prevents and corrects multiple types of discoloration. This product contains tranexamic acid and niacinamide for pigmentation, hepes for hydration, and kojic acid to brighten skin and help to reduce the amount of melanin produced. These ingredients work together to help break up existing melanin clusters, inhibit the formation of melanocytes, and deactivate inflammatory mediators. The serum provides a reduction in visible and stubborn pigmentation for a revitalized and even complexion with refined texture and clarity. For more information, visit www.skinceuticals.com.
Eskata
Aclaris Therapeutics, Inc, announces US Food and Drug Administration approval of Eskata (hydrogen peroxide) topical solution 40% for the treatment of raised seborrheic keratoses. This product is a targeted, in-office treatment applied directly to raised seborrheic keratoses using a penlike applicator. Clinical studies showed clearing of seborrheic keratoses after 2 treatments. Eskata is expected to be commercially available in the spring of 2018. For more information, visit www.eskata.com.
Ixifi
Pfizer Inc announces US Food and Drug Administration approval of Ixifi (infliximab-qbtx), a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product. Ixifi has been approved in the United States as a treatment for rheumatoid arthritis, Crohn disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. For more information, visit www.pfizer.com.
Jemdel
Ortho Dermatologics announces US Food and Drug Administration acceptance of the New Drug Application for Jemdel (halobetasol propionate 0.01%), a high-potency topical steroid for the treatment of plaque psoriasis with dosing for as long as 8 weeks. Jemdel has a Prescription Drug User Fee Act action date of October 5, 2018. For more information, visit www.ortho-dermatologics.com.
Retin-A Micro
Ortho Dermatologics announces that Retin-A Micro (tretinoin) gel microsphere 0.06%, a topical treatment for acne vulgaris, will be available commercially to health care professionals. The US Food and Drug Administration previously approved the Supplemental New Drug Application for this product in October 2017. Retin-A Micro features a microsponge delivery system technology that helps control the release of tretinoin and improves photostability, even when used in conjunction with benzoyl peroxide. This product also features a pump delivery system for controlled dispensing and consistent dosing. Caution should be exercised when prescribing to eczema patients and nursing mothers. For more information, visit www.retinamicro.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Avène TriXera
Pierre Fabre Dermo-Cosmetique launches the Avène TriXera line consisting of 3 products. The TriXera Nutrition Nutri-fluid Cleanser gently cleanses and nourishes dry to very dry, sensitive skin. TriXera Nutrition Nutri-fluid Lotion offers 48-hour hydration for dry, sensitive skin. These nourishing effects last up to 6 hours after application. TriXera Nutrition Nutri-fluid Balm has a fluidlike texture and also offers 48-hour hydration. All 3 products contain Avène Thermal Spring Water to soothe and soften as it restores the skin’s balance, as well as evening primrose oil and soy extract to rebuild the skin barrier and prevent moisture loss. For more information, visit www.aveneusa.com.
CoolSculpting
Allergan plc announces US Food and Drug Administration clearance for the CoolSculpting treatment, a nonsurgical fat reduction technology for improved appearance of lax tissue in conjunction with submental fat. CoolSculpting works by gently cooling targeted fat cells in the body to induce natural, controlled elimination of fat cells without affecting surrounding tissue. For more information, visit www.coolsculpting.com.
Discoloration Defense
SkinCeuticals introduces Discoloration Defense, a high-potency treatment serum that prevents and corrects multiple types of discoloration. This product contains tranexamic acid and niacinamide for pigmentation, hepes for hydration, and kojic acid to brighten skin and help to reduce the amount of melanin produced. These ingredients work together to help break up existing melanin clusters, inhibit the formation of melanocytes, and deactivate inflammatory mediators. The serum provides a reduction in visible and stubborn pigmentation for a revitalized and even complexion with refined texture and clarity. For more information, visit www.skinceuticals.com.
Eskata
Aclaris Therapeutics, Inc, announces US Food and Drug Administration approval of Eskata (hydrogen peroxide) topical solution 40% for the treatment of raised seborrheic keratoses. This product is a targeted, in-office treatment applied directly to raised seborrheic keratoses using a penlike applicator. Clinical studies showed clearing of seborrheic keratoses after 2 treatments. Eskata is expected to be commercially available in the spring of 2018. For more information, visit www.eskata.com.
Ixifi
Pfizer Inc announces US Food and Drug Administration approval of Ixifi (infliximab-qbtx), a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product. Ixifi has been approved in the United States as a treatment for rheumatoid arthritis, Crohn disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. For more information, visit www.pfizer.com.
Jemdel
Ortho Dermatologics announces US Food and Drug Administration acceptance of the New Drug Application for Jemdel (halobetasol propionate 0.01%), a high-potency topical steroid for the treatment of plaque psoriasis with dosing for as long as 8 weeks. Jemdel has a Prescription Drug User Fee Act action date of October 5, 2018. For more information, visit www.ortho-dermatologics.com.
Retin-A Micro
Ortho Dermatologics announces that Retin-A Micro (tretinoin) gel microsphere 0.06%, a topical treatment for acne vulgaris, will be available commercially to health care professionals. The US Food and Drug Administration previously approved the Supplemental New Drug Application for this product in October 2017. Retin-A Micro features a microsponge delivery system technology that helps control the release of tretinoin and improves photostability, even when used in conjunction with benzoyl peroxide. This product also features a pump delivery system for controlled dispensing and consistent dosing. Caution should be exercised when prescribing to eczema patients and nursing mothers. For more information, visit www.retinamicro.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
