CDERNEW-TEXT 10/10/2007
Wednesday, October 10, 2007
October 10, 2007
Approved Drug Products with Therapeutic Equivalence Evaluations Orange
Book http://www.fda.gov/cder/orange/default.htm
Drug Shortage: Drug to be Discontinued; Agenerase (amprenavir) 150mg
capsule http://www.fda.gov/cder/drug/shortages/default.htm#Agenerase
(updated)
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA approves the first generic versions of Trileptal (oxcarbazepine), an
anticonvulsant drug
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01721.html
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo, Labeling Revision
CUBICIN (daptomycin) Injection, Cubist Pharma, Labeling Revision
Depo-subQ provera 104 (medroxyprogesterone acetate injectable
suspension), Pfizer Global, Labeling Revision
Pexeva (paroxetine mesylate) Tablets, JDS Pharma, Labeling Revision
Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates,
Control Supp.
Risedronate Sodium Tablets, Teva Pharma, Approval
Romazicon (flumazenil) Injection, HLR Technology, Labeling Revision
Tamiflu (oseltamivir phosphate) Capsules, Hoffman La Roche, Labeling
Revision
Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman La Roche,
Labeling Revision
Prescription Drug User Fee Rates for Fiscal Year 2008
http://www.fda.gov/OHRMS/DOCKETS/98fr/OC2007240-n0000001.pdf PDF
http://www.fda.gov/graphics/pdf.gif
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 4:34 PM,
