CDERNEW-TEXT 8/20 & 21/2007
Tuesday, August 21, 2007
August 21, 2007
Cyber Letters http://www.fda.gov/cder/warn/cyber/cyber2007.htm
(updated)
Manuals of Policies and Procedures (MaPP) 6050.1R
http://www.fda.gov/cder/mapp/6050.1R.pdf
Refusal to Accept Application
for Filing From Applicants in Arrears
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Albenza (albendazole) Tablets, GlaxoSmithKline, Labeling Revision
BiCNU (carmustine) Injection, Bristol Squibb, Manufacturing Change or
Addition
Clarithromycin Tablets, Apotex Inc., Approval
Diovan (valsartan) Tablets, Novartis Pharma, Labeling Revision
Epirubicin Hydrochloride Injection, Dabur Oncology, Approval
Fentanyl Transdermal System, Watson Labs, Approval
Fentanyl Transdermal System, Actavis, Approval
Provigil (modafinil) Tablets, Cephalon Inc., Labeling Revision
Pulmicort Turbuhaler (budesonide) Inhalation Powder, AstraZeneca Pharma,
Labeling Revision
Reclast (zoledronic acid) Injection, Novartis Pharma, Approval
Tykerb (lapatinib) Tablets, SmithKline Beecham, Labeling Revision
Zolpidem Tartrate Tablet, Torrent Pharma, Approval
August 20, 2007
Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)
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posted by Mags @ 4:52 PM,
