Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women
Supernus Pharmaceuticals, Inc. (SUPN)
Last supernus pharmaceuticals, inc. earnings: 2/25 04:40 pm
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Source: GlobeNewswire
Updated label includes new data in Section 12.2, detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting Qelbree’s multimodal pharmacodynamicsQelbree is the first ADHD treatment to meet its post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies1 ROCKVILLE, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic
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SUPN
Earnings
- 11/4/25 - Miss
SUPN
Sec Filings
- 12/19/25 - Form 144
- 12/19/25 - Form 4
- 11/24/25 - Form 4
- SUPN's page on the SEC website