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Details:
QSIVA is a combination of phentermine, a sympathomimetic amine anorectic and topiramate extended-release, an antiepileptic drug. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity.
Lead Product(s): Phentermine,Topiramate
Therapeutic Area: Nutrition and Weight Loss Product Name: Qsiva
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mayo Clinic
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2023
Details:
The U.S. FDA has approved Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, the generic version of Qudexy®1 XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC.
Lead Product(s): Topiramate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2021
Details:
Marketing Application for ET-101 was submitted for monotherapy to treat primary general tonic-clonic seizures in patients at least two years old, adjunctive therapy for treatment of partial-onset seizures, and as preventative treatment of migraine in patients, two years old.
Lead Product(s): Topiramate
Therapeutic Area: Neurology Product Name: ET-101
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
Results demonstrated bioequivalence to the currently approved oral solid formulation.
Lead Product(s): Topiramate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2020
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