Hot off the Press Archives - Dr. Tatiana Khrom

Thermi receives notice of complete and satisfactory closure of FDA’s “vaginal rejuvenation” inquiry

Posted By Dr. Tatiana Khrom

IRVING, TEXAS (November 15, 2018) – Thermi®, an Almirall, S.A. company, today announced that it has received a notice of completion to a U.S. Food and Drug Administration (FDA) inquiry on products used in “vaginal rejuvenation” procedures. Thermi received an “It has come to our attention” notice from the FDA on July 24, 2018 regarding specific claims about the company’s ThermiVa® device in the United States. ThermiVa, a non-ablative radiofrequency application, has been cleared by the FDA for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. All Thermi products are marketed in accordance with their FDA-cleared indications, … Continue reading

FDA Approves Sarecycline for Moderate to Severe Acne

Posted By Dr. Tatiana Khrom

The US Food and Drug Administration (FDA) has approved sarecycline (Seysara, Almirall) for patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. Sarecycline is a new first-in-class tetracycline-derived oral antibiotic and the first one specifically designed for dermatologic use in 40 years, according to a company news release. “We are proud to have obtained the FDA’s approval for Seysara, which will bring a new option for the many patients with unmet medical needs,” Peter Guenter, chief executive officer, Almirall, said in the news release. Sarecycline is a once-daily oral tablet with anti-inflammatory … Continue reading

FDA Approves Dermira’s Qbrexza Cloth to Treat Primary Axillary Hyperhidrosis

Posted By Dr. Tatiana Khrom

The FDA has approved Qbrexza (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older. Qbrexza is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation. Approval is based on results from two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production (the weight or amount of sweat a patient produced) following treatment with Qbrexza … Continue reading

FDA Greenlight Restylane Lyft for Hand Rejuvenation

Posted By Dr. Tatiana Khrom

Restylane Lyft is the first hyaluronic acid (HA) injectable gel approved for use on the dorsal hands of people older than 21, thanks to recent FDA approval. Radiesse (Calcium Hydroxylapatite) is also approved for the correction of lost volume in hands. “As we age, we lose volume in the back of the hands, causing the appearance of tendons, wrinkles and veins to become more pronounced,” says Ellen Marmur, MD a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft in the hands. “Many of my patients start to notice their youthful-looking faces aren’t matching their aging … Continue reading

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Thermi receives notice of complete and satisfactory closure of FDA’s “vaginal rejuvenation” inquiry

FDA Approves Sarecycline for Moderate to Severe Acne

FDA Approves Dermira’s Qbrexza Cloth to Treat Primary Axillary Hyperhidrosis

FDA Greenlight Restylane Lyft for Hand Rejuvenation