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Drug: New Drug Applications
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Total 13 results found since Jan 2013.
FDA Rejects Schizophrenia Tx; ADHD & Mental Health; Eating Disorder Treatment Scarce
(MedPage Today) -- The FDA hit Teva Pharmaceuticals and MedinCell with a complete response letter in regard to their new drug application for the schizophrenia treatment TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous...
Source: MedPage Today Psychiatry - April 20, 2022 Category: Psychiatry Source Type: news
Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients
ROCKVILLE, Md., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS)...
Source: Drugs.com - New Drug Applications - February 8, 2021 Category: Drugs & Pharmacology Source Type: news
Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
If approved, AR19 would be the first-ever FDA-approved ADHD stimulant medication designed to resist manipulation for nonmedical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration
ATLANTA, May 13... Biopharmaceuticals, FDA Arbor Pharmaceuticals, amphetamine, ADHD
Source: HSMN NewsFeed - May 13, 2020 Category: Pharmaceuticals Source Type: news
Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD
ROCKVILLE, Md., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS)...
Source: Drugs.com - New Drug Applications - November 11, 2019 Category: Drugs & Pharmacology Source Type: news
FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a...
Source: Drugs.com - New Drug Applications - August 31, 2018 Category: Drugs & Pharmacology Source Type: news
Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) November 10, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel...
Source: Drugs.com - New Drug Applications - November 10, 2017 Category: Drugs & Pharmacology Source Type: news
Sunovion submits NDA for dasotraline to US FDA to treat ADHD patients
Sunovion Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline to treat patients with attention deficit hyperactivity disorder (ADHD).
Source: Pharmaceutical Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news
Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dasotraline, a novel...
Source: Drugs.com - New Drug Applications - August 31, 2017 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Acknowledges Receipt of Shire ’s New Drug Application for SHP465 for ADHD
Lexington, Mass., USA – January 19, 2017 –– Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a...
Source: Drugs.com - New Drug Applications - January 19, 2017 Category: Drugs & Pharmacology Source Type: news
Alcobra Provides Update on Recent FDA Meeting and Path Forward for MDX Clinical Development Program
TEL AVIV, Israel, Jan. 09, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity...
Source: Drugs.com - New Drug Applications - January 9, 2017 Category: Drugs & Pharmacology Source Type: news
Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD
DALLAS/FORT WORTH, Texas, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary...
Source: Drugs.com - New Drug Applications - December 20, 2016 Category: Drugs & Pharmacology Source Type: news
Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment of ADHD
DALLAS/FORT WORTH, Texas, Nov. 17, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit...
Source: Drugs.com - New Drug Applications - November 17, 2016 Category: Drugs & Pharmacology Source Type: news
Neos Therapeutics raises $20.6M to support ADHD drug pipeline
Pharmaceutical company Neos Therapeutics Inc. has completed a round of financing totaling $20.6 million for its late-stage pipeline of extended-release products for Attention-Deficit Hyperactivity Disorder, the Grand Prairie-based firm announced Wednesday.
The funding will support its efforts during the regulatory review of its ADHD drug candidate. The company has been raising late-stage funding in the past year.
In January, the company submitted a new drug application to the U.S. Food and Drug…
Source: bizjournals.com Health Care:Physician Practices headlines - February 25, 2015 Category: American Health Authors: Bill Hethcock Source Type: news
