WAKIX Gets Additional FDA Approval—for Cataplexy
FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on two randomized, controlled trials.
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LatestSomnetics 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.
![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-150x150.jpg)
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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...
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...
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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 MoreFDA Grants Orphan Drug Designation to XW Laboratories’ XWL-008 for Narcolepsy
XW Laboratories Inc, a China-based clinical-stage biopharmaceutical company pioneering the discovery of novel small molecule therapeutics for the treatment of neurological disorders, has received the U.S. Food and Drug...
Read MoreApple Watch App for Nightmare Disorder Receives FDA Breakthrough Designation, Opens Enrollment for Two RCTs
To see light as a prescription digital therapeutic for PTSD patients affected by nightmares, NightWare is testing its app among veterans and the general public, reports MobiHealthNews. “[Breakthrough status] is a really nice...
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FDA Requires Black Box Warning on Certain Prescription Insomnia Medicines
The US Food and Drug Administration (FDA) today announced the agency is requiring a new boxed...
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Zyppah Gets FDA Over-The-Counter 510k Nod Allowing It to Sell Its Anti-Snoring Oral Appliance via Third-Party Retail Marketplaces
After six years on the market, Zyppah has been granted US Food and Drug Administration (FDA)...
Read MoreFDA to Review New Drug Application for Lemborexant for Insomnia
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. A Prescription Drug...
Read MoreFDA Reclassifies Auto Titration Device for Oral Appliances to Enhance Patient Access to Beneficial Innovation
The FDA recently issued a final order to reclassify auto titration devices for oral appliances to Class II devices.
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Sleep Medicine FDA Clearances and Approvals 2018
Sleep Review’s annual roundup of the devices, pharmaceuticals, and more that recently earned...
Read MoreNew HETLIOZ Patent Listed in the FDA Orange Book
Vanda Pharmaceuticals Inc announced that a HETLIOZ patent, number 10,071,977 (‘977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence...
Read MoreCompass Health Brands Recalls CPAP Mask Cushion Devices Due to Possible Air Leaks
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The following recall has been posted on FDA.gov. Recalled Product(s): Replacement...
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