CDERNEW-TEXT 10/11/2007
Thursday, October 11, 2007
October 11, 2007
Guidance for Industry: Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed without an Approved
Application [PDF http://www.fda.gov/cder/guidance/7950dft.pdf ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension,
Bristol-Myers Squibb, Labeling Revision
Omnipred (prednisolone acetate) Ophthalmic Suspension, Alcon Labs,
Labeling Revision
Oxcarbazepine Tablets, Glenmark Pharma, Approval
Oxcarbazepine Tablets, Sun Pharma, Approval
Oxcarbazepine Tablets, Roxane Labs, Approval
Simvastatin Orally Disintegrating Tablets, Synthon Pharma, Approval
Velcade (bortezomib) Injection, Millennium Pharma, Efficacy Supp.
w/Clinical Data
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 5:23 PM,
,
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,
,
CDERNEW-TEXT 10/10/2007
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
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 10:36 AM,
,