CDERNEW-TEXT 10/31/2007
Thursday, November 1, 2007
October 31, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA approves Tasigna (nilotinib) for the treatment of Philadelphia
chromosome positive chronic myeloid leukemia
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01734.html .
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Baclofen 10mg Tablets, Impax Labs, Approval
Baclofen 20mg Tablets, Impax Labs, Approval
Cetirizine Hydrochloride Syrup, Taro Pharma, Tentative Approval
Cetirizine Hydrochloride Tablets, Cipla Ltd., Tentative Approval
Fenofibrate Tablets, Par Pharma, Control Suppl.
Levocarnitine Oral Solution, P3 Labs, Approval
Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol,
Astra Zeneca, Control Supp.
Requesting a Pre-Assigned Electronic Common Technical Document (eCTD)
Number from Office of Generic Drugs
http://www.fda.gov/cder/ogd/request_preassigned_ectd.htm
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posted by Mags @ 11:23 AM,
