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Drug Evaluation & Research

CDERNEW-TEXT 10/22 & 23/2007


Tuesday, October 23, 2007

October 23, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Coreg CR (carvedilol phosphate) Extended-release Capsules, SB Pharmco,
Labeling Revision

Granisetron Hydrochloride Injection, Teva Parenteral, Tentative
Approval

Granisetron Hydrochloride Tablet, Cipla Ltd., Tentative Approval

Glyburide Tablets, Aurobindo Pharma, Approval

LEVITRA (vardenafil hydrochloride) Tablets, Bayer Pharma, Labeling
Revision

Repraxain (Hydrocodone Bitartrate and Ibuprofen) Tablets, Interpharm
Inc., New Strength & Labeling

SORIATANE (acitretin) Capsules, Stiefel Labs, Labeling Revision

October 22, 2007

FDA approves Ixempra (ixabepilone) for advanced breast cancer patients
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01732.html .

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

CIALIS (tadalafil) Tablets, Lilly Icos Inc., Labeling Revision

Colgate Total Toothpaste (sodium fluoride and triclosan dentifrice),
Colgate-Palmolive, Formulation Revision

Escitalopram Oxalate Tablets, Sandoz, Tentative Approval

Granisetron Hydrochloride Injection, Baxter Healthcare, Tentative
Approval

Ketoconazole Shampoo, Tolmar Inc., Formulation Revision

Losartan Potassium and Hydrochlorothiazide Tablets, TEVA Pharma,
Tentative Approval

Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision

Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision

Torsemide Tablets, Aurobindo Pharma, Approval

Vexol (rimexolone ophthalmic suspension), Alcon Labs, Labeling Revision

VIAGRA (sildenafil citrate) Tablets, Pfizer Inc., Labeling Revision

Voltaren Gel (diclofenac sodium) Topical Gel, Novartis, Approval

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posted by Mags @ 4:38 PM,




1 Comments:

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