Back to Results
First PageMeta Content
Food law / Pharmaceutical sciences / Pharmaceuticals policy / Drug safety / Pharmaceutical industry / Structured Product Labeling / New Drug Application / Federal Food / Drug / and Cosmetic Act / Lisdexamfetamine / Food and Drug Administration / Medicine / Health


Document Date: 2009-04-02 11:04:30

Open Document

File Size: 171,64 KB

Share Result on Facebook

Company

S-001 NDA APPROVAL Shire Development Inc. / /

Event

FDA Phase / /

Facility

National Library of Medicine / /

IndustryTerm

treatment of attention deficit hyperactivity disorder / proposed introductory advertising / drug product / /

MedicalCondition

attention deficit hyperactivity disorder / /

Organization

Food and Drug Administration Center for Drug Evaluation / Psychiatry Products Office / Food and Drug Administration / DEPARTMENT OF HEALTH / Research Division of Drug Marketing / Advertising / and Communications / Division of Drug Marketing / Advertising / and Communications / /

Person

Thomas Laughren / Elisa Schneider / Janet Cliatt / /

/

Position

Manager / Regulatory Affairs / Regulatory Project Manager / Director Division / M.D. Director Division / /

Product

Vyvanse / S-001 / Vyvanse (lisdexamfetamine dimesylate) / HFD-001 / /

ProvinceOrState

Maryland / Pennsylvania / /

URL

http /

SocialTag