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Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed-dose combination medication for the treatment of hepatitis C in adults. [ 2 ] [ 5 ] [ 6 ] [ 7 ] It combines sofosbuvir and velpatasvir .
A fourth study provided information about the safety of viloxazine in adolescents 12 to 17 years of age with ADHD. [34] The FDA approved viloxazine based on evidence from several clinical trial(s) of 1289 participants with attention deficit hyperactivity disorder (ADHD). [34] The trials were conducted at 59 sites in the United States. [34]
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
This is a list of investigational attention deficit hyperactivity disorder drugs, or drugs that are currently under development for clinical use in the treatment of attention deficit hyperactivity disorder (ADHD) but are not yet approved. Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in ...
This is a complete list of clinically approved prescription antidepressants throughout the world, as well as clinically approved prescription drugs used to augment antidepressants or mood stabilizers, by pharmacological and/or structural classification.
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Administrative information and prescribing information. Common technical document summaries. Quality. Nonclinical study reports. Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions)
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...
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