NDA Submitted for Novel Insomnia Treatment Lemborexant
The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.
All articles by Steve Duffy, Digital Content Editor
NDA for Transdermal Patch Formulation of Asenapine Submitted to FDA
An NDA has been submitted to the FDA for a transdermal patch formulation of asenapine for the treatment of schizophrenia.
Evzio Authorized Generic Soon to Be Available
An authorized generic version of Evzio is expected to be available next year at a price of $178 per carton.
Perseris Now Available for the Treatment of Schizophrenia in Adults
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
FDA Committees Vote on Opioid System Modulator for MDD Treatment
In the meeting documents, the panel presented a scenario which illustrated their concerns regarding potentially complex drug interactions that may occur in the population for which the drug is intended.
Red Cross Releases Online Course on How to Respond to an Opioid Overdose
The training has information on how to use several products including a nasal atomizer, Narcan Nasal Spray and Evzio.
Psilocybin Gets Breakthrough Therapy Designation for Treatment-Resistant Depression
Psilocybin, the active ingredient in “magic mushrooms”, has been granted Breakthrough Therapy designation by the FDA for treatment-resistant depression.
FDA Issues Safety Communication Regarding Pen Needle Use
Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.
NDA Submitted for Novel Schizophrenia Treatment Lumateperone
Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation.
FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis
The new plan will break out the current guidance into 4 separate guidances.
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