CDERNEW-TEXT 10/10/2007
Wednesday, October 10, 2007
October 9, 2007
BPCA/Pediatric Exclusivity Statistics:
Breakdown of Requested Studies Report
http://www.fda.gov/cder/pediatric/breakdown.htm
(updated)
Spectrum of Diseases/Conditions
http://www.fda.gov/cder/pediatric/specdis.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)
CDER Organization Charts [HTML http://www.fda.gov/cder/cderorg.htm ]
[PDF http://www.fda.gov/cder/cderorg/cder-all.pdf ] (updated)
Current Drug Shortage
Solu-Cortef 100mg (Hydrocortisone sodium succinate) for injection
http://www.fda.gov/cder/drug/shortages/default.htm#Valstar
(updated)
Valstar (valrubicin) Solution for Intravesical Instillation
http://www.fda.gov/cder/whatsnew.htm#Valstar (updated)
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Accutane (isotretinoin) Capsules, Hoffman La-Roche, Labeling Revision
Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharma, Accelerated
Approval
Cetirizine Hydrochloride Chewable Tablets, Caraco Pharma, Tentative
Approval
Estradiol Valerate Injection, Sandoz Inc., Approval
Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval
Hydrochlorothiazide Tablets, Apotex, Approval
Irinotecan Hydrochloride Injection, Abraxis Pharma, Tentative Approval
LEXXEL (enalapril maleate-felodipine ER) Tablets, AstraZeneca, Labeling
Revision
Nifedipine Extended-release Tablets, Osmotica Pharma, Approval
Qualaquin (quinine sulfate) Capsules, AR Holding Co., Labeling Revision
Sensipar (cinacalcet) Tablets, Amgen Inc., Labeling Revision
Torsemide Tablets, Apotex, Supplier Addition
Valacyclovir Hydrochloride Tablets, Teva Pharma, Tentative Approval
VUSION (miconazole nitrate, zinc oxide, white petrolatum) Ointment,
Barrier Therapeutics, Labeling Revision
Zestril (lisinopril) Tablets, AstraZeneca, Labeling Revision
Zestoretic (lisinopril/hctz) Tablets, AstraZeneca, Labeling Revision
Zoloft (sertraline hydrochloride) Tablets, Pfizer Pharma, Labeling
Revision
Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer Pharma,
Labeling Revision
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posted by Mags @ 10:36 AM,
