Drugs

On 2nd Try, Vaginal Pain Drug Approved

FDA has approved a TherapeuticsMD NDA resubmission for Imvexxy (estradiol vaginal inserts) for treating moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, due to menopause. FDA 5/2017 rejected an earlier submission, raising concern about a lack of long-term endometrial safety data beyond the 12 weeks studied in the pivotal phase 3 Rejoice Trial, the company said at the time (see story). The agency subsequently reversed its decision for more data before approval — a move that may signal the agency’s increasing reliance on real world data. The NDA resubmission was permitted with the company committing to conduct a post-approval observational study

Imvexxy is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market, according to the company. Its mechanism of action is the re-estrogenization of the tissue in and around the vagina, and it is administered daily for two weeks followed by only twice a week dosing. The most common adverse reaction reported in clinical trials was headache. The approval also carries a boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome