SOMNOmedics PSGs Now FDA Approved for Pediatric Use
The FDA approval is for children as young as 2 years old. Specific analysis templates for children are available in DOMINO software.
Category: FDA
FDA
Latest
FDA
LatestSommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea
AerSleep II applies negative pressure over the external surface of the neck to hold the airway open. It is self-contained with an integral vacuum pump.
FDA
PopularMylan Launches Generic of Nuvigil Tablets
Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the Food and Drug Administration (FDA) for its...
These Sleep Medicine Products Got FDA Nod in 2019
Sleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.
Read MoreSomnetics Gets FDA Emergency Use Authorization for BiPAPs and Respiratory Circuits
The Minnesota-based CPAP manufacturer is supporting local and regional medical communities with an emergency supply of EUA BiPAP devices purchased by the state of Minnesota and South Dakota medical facilities.
Read MoreVanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome
Vanda Pharmaceuticals Inc has completed a Type A Meeting with the US Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ (tasimelteon) for the treatment of Smith-Magenis Syndrome.
Read MoreFDA: CPAPs May be Used to Support Patients with Respiratory Insufficiency During the Coronavirus Disease 2019 Outbreak
In a letter to health care providers dated March 20, the US Food and Drug Administration advises the following.
Read MoreFDA Warning Letter: EPAP Mask Maker Is Misbranding Its Snoring Device
CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...
Read More![FDA Preliminary Lab Tests: Several CPAP Cleaners Generate Ambient Levels of Ozone Above Safe Limits [Video]](https://www.sleepreviewmag.com/wp-content/uploads/2020/03/ozone-cpap-cleaners-627x376.jpg)
FDA Preliminary Lab Tests: Several CPAP Cleaners Generate Ambient Levels of Ozone Above Safe Limits [Video]
The FDA issued a Safety Communication to inform patients and health care providers that devices claiming to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light are not legally marketed for this use by the FDA in the United States, and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown.
Read More
Prescribing Info Update: BELSOMRA Improves Total Sleep Time, WASO in Study of Mild-to-Moderate Alzheimer’s Disease Patients
Merck has received approval from the U.S. Food and Drug Administration (FDA) for an update to the...
Read MorePublic Notification: U-Dream Full Night Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use U-Dream Full Night, a product promoted and sold as a sleep aid on various websites, as an FDA aboratory analysis confirmed that U-Dream...
Read More
FDA Warns of Serious Breathing Problems with Gabapentinoids When Used with CNS Depressants or in Patients with Lung Problems
An FDA-approved drug for restless legs syndrome is included. The US Food and Drug Administration...
Read More
FDA Responds to Citizen Petitions Requesting Black Box Warnings on Dopamine Agonists for Restless Legs Syndrome
In a 39-page letter dated October 21, 2019, the US Food and Drug Administration (FDA) responded to...
Read MoreDrug Trials Snapshots: WAKIX
The FDA recently published a drug trials Snapshot on Wakix for narcolepsy, which highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race...
Read MoreAvadel Gets FDA OK to Reduce Sample Size for Once-nightly Sodium Oxybate Phase 3 Study
Avadel Pharmaceuticals plc, a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, reports that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to...
Read More
FDA Seeks Pulmonary and Dental Sleep Experts for Medical Devices Advisory Committee Panels
The US Food and Drug Administration (FDA) issued a notice requesting nominations for voting...
Read MoreFDA To Vanda: HETLIOZ Jet Lag Disorder Measures of “Unclear Clinical Significance”
Vanda Pharmaceuticals Inc received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Aug 16 as part of the FDA’s ongoing review of Vanda’s supplemental New Drug Application...
Read MoreVanda Receives FDA Deficiencies Notice for Hetlioz Supplemental New Drug Application for Jet Lag Disorder; Vanda Plans to Work with FDA to Resolve
Vanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ...
Read More