CDERNEW-TEXT 9/7/2007
Friday, September 7, 2007
September 7, 2007
BPCA/Pediatric Exclusivity Statistics:
Pediatric Exclusivity Statistics
http://www.fda.gov/cder/pediatric/exgrant.htm
(updated)
Written Requests Issued http://www.fda.gov/cder/pediatric/wrlist.htm
(updated)
Written Requests Statistics
http://www.fda.gov/cder/pediatric/wrstats.htm
(updated)
Efficacy Supplement Approvals http://www.fda.gov/cder/rdmt/ESCY07AP.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Amlodipine Besylate Tablets, Wockhardt, Approval
Carvedilol Tablets, Glenmark Pharma, Approval
Carvedilol Tablets, Aurobindo Pharma, Approval
Carvedilol Tablets, Lupin, Approval
Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma,
Labeling Revision
Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling
Revision
Omniscan (gadodiamide) Injection, GE Healthcare, Approval
Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval
Topiramate Capsules, Mylan Pharma, Tentative Approval
Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 5:41 PM,
