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  2. Sofosbuvir/velpatasvir - Wikipedia

    en.wikipedia.org/wiki/Sofosbuvir/velpatasvir

    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 .

  3. Viloxazine - Wikipedia

    en.wikipedia.org/wiki/Viloxazine

    [6] [1] [5] The immediate-release form has an elimination half-life of 2.5 hours [6] [2] while the half-life of the extended-release form is 7 hours. [1] Viloxazine was first described by 1972 [10] and was marketed as an antidepressant in Europe in 1974. [6] [11] It was not marketed in the United States at this time. [12]

  4. List of investigational attention deficit hyperactivity ...

    en.wikipedia.org/wiki/List_of_investigational...

    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 ...

  5. Liquidia's inhaled drug fails to get traditional approval in ...

    www.aol.com/news/us-fda-grants-tentative...

    (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 ...

  6. PDUFA date - Wikipedia

    en.wikipedia.org/wiki/PDUFA_date

    The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.

  7. UPDATE: With Multimedia: U.S. FDA Approves ELIQUIS ... - AOL

    www.aol.com/news/2013-01-02-update-with...

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  8. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...

  9. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

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