X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
Details:
PluriPain-PMS, an advanced, all natural anti-inflammatory and mood-enhancing Women’s Health formula to combat specific symptoms associated with the menstrual cycle.
Lead Product(s): Vitamin D,Calcium,Potassium
Therapeutic Area: Immunology Product Name: PluriPain-PMS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2023
Details:
Xywav (Calcium) is a lower-sodium oxybate approved by FDA for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia in adults.
Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
This FDA approval is based on the global Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study that demonstrated the efficacy and safety of Xywav for the treatment of idiopathic hypersomnia in adults.
Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2021
Details:
Results from the Phase 3, placebo-controlled, double-blind, randomized withdrawal study of Xywav in adults with idiopathic hypersomnia including an oral presentation of the correlation of the idiopathic hypersomnia severity scale score with other measures of sleep parameters.
Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2021
Details:
Xywav demonstrated highly statistically significant differences in median change in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo.
Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
All patients were treated with Xywav during the open-label titration period and clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) were observed.
Lead Product(s): Calcium,Magnesium,Potassium
Therapeutic Area: Sleep Product Name: Xywav
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
