FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure
The U.S. Food and Drug Administration issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure—a permanent birth control device Bayer sold in the U.S. until 2018. The letter applies to reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding Essure.
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments
The U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy represents a new targeted therapy for patients living with this aggressive malignancy,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. The approval provides patients who’ve already tried two prior therapies with a new option.”
FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer
As part of Project Orbis, the U.S. Food and Drug Administration approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.
FDA approves niraparib for first-line maintenance of advanced ovarian cancer
On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
FDA approves new treatment for a type of heart failure
The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Heart failure occurs when the heart does not pump enough blood to support the body’s needs, and this type of heart failure happens when the heart’s main pumping chamber, the left ventricle, is weakened. With the approval, Farxiga is the first in this particular drug class, sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.
FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction
The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.
Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications
Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of specific lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table to the consumer/user level. These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.
Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753
Trividia Health, Inc. announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.
The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.
FDA grants marketing of new device for continuous hemodialysis therapy for use in pediatric patients with certain kidney conditions
The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Continuous hemodialysis or hemofiltration therapy – known as continuous renal replacement therapy (CRRT) – involves using a dialysis machine and a special filter, or dialyzer, to continuously clean a patient’s blood for an extended period of time, without stopping, instead of the more traditional three times a week therapy session. CRRT is typically performed in intensive care unit (ICU) settings. The CARPEDIEM System is the first CRRT device intended for a lower weight-specific pediatric patient population (2.5 and 10 kilograms; or 5.5 to 22 pounds) who have a sudden or temporary loss of kidney function (acute kidney injury) or have too much water in their bodies because their kidneys are not functioning properly (fluid overload).
FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market
The U.S. Food and Drug Administration issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
The U.S. Food and Drug Administration approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). Sevenfact contains an active ingredient expressed in genetically engineered rabbits.
“The approval provides another treatment option for the control of bleeding episodes in adults and adolescents with hemophilia who have developed inhibitors,” said Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to being an important option for patients, Sevenfact is the first product for hemophilia treatment that contains an active ingredient obtained from rabbits genetically engineered to produce a protein necessary for blood coagulation. This approval is an example of our efforts to advance safe biotechnology innovations to support patient health.”
.png)
No hay comentarios:
Publicar un comentario