FDA Alerts
FDA Expands Indication For Breast Cancer Rx
On February 19, 2016, the U. S. Food and Drug Administration approved palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
Hypoactive Sexual Desire Disorder Rx Approved
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.
FDA Recommends Adding Boxed Warning to Laparoscopic Power Morcellators
Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids.
FDA Permits Marketing of Urinary Prosthesis Device for Women
The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).
FDA Issues Advice on Eating Fish
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued draft updated advice on fish consumption.
FDA Likely to Address Risks of Surgical Mesh
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP).
FDA Approves the First Non-Hormonal Treatment for Hot Flashes Associated with Menopause
The US Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause.
FDA Approves Plan B One-Step Emergency Contraceptive for Use Without a Prescription
Today, the US Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.
FDA Approves new Silicone Gel-filled Breast Implant
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.