CDERNEW-TEXT 8/22/2007
Wednesday, August 22, 2007
August 22, 2007
FDA approves Risperdal (risperidone) for two psychiatric conditions in
children and adolescents. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01686.html
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
ALOCRIL (nedocromil sodium) Ophthalmic Solution, Allergan Inc., Labeling
Revision
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets,
SB Pharmco, Labeling Revision
Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco,
Labeling Revision
Escitalopram Oxalate Tablets, Invagen Pharma, Tentative Approval
Phentermine Hydrochloride Tablets, Caraco Pharma, Approval
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 5:13 PM,
,
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)
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 4:52 PM,
,