Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) Receives Not Approvable Letter From FDA For Tipifarnib Based On Phase II Data
RARITAN, N.J., June 30, 2005 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) for the tipifarnib new drug application (NDA), which was based on data from a single Phase II study. Tipifarnib is an oral medication studied to treat acute myeloid leukemia (AML) in elderly patients who are not candidates for standard chemotherapy. The not approvable letter explains why the NDA cannot be approved based on currently submitted data. New! Sign up for local CML support group meetings in your local community at http://cml.meetup.com Apply for Commercial Real Estate loans online and submit your deal to dozens of hungry lenders in just minutes. Loan programs for all types of business and commercial real estate. Apply anytime at http://realestatezoo.com CML (Chronic Myelogenous Leukemia Support List) --------------------------------- Part Of CMLHope.Com An International Community Of CML Patients For more information: http://cmlhope.com Post Message: [email protected] Subscribe: [EMAIL PROTECTED] Unsubscribe: [EMAIL PROTECTED] Change To No Mail/Web: [EMAIL PROTECTED] Change To Digest: [EMAIL PROTECTED] Change To Email: [EMAIL PROTECTED] List Help: [EMAIL PROTECTED] CML Group Web Site http://groups.yahoo.com/group/CML Yahoo! Groups Links <*> To visit your group on the web, go to: http://groups.yahoo.com/group/CML/ <*> To unsubscribe from this group, send an email to: [EMAIL PROTECTED] <*> Your use of Yahoo! Groups is subject to: http://docs.yahoo.com/info/terms/
