Drug Evaluation & Research: 9/2/07

CDERWEEK-TEXT 9/4 - 7/2007

Friday, September 7, 2007

September 7, 2007

BPCA/Pediatric Exclusivity Statistics:

Pediatric Exclusivity Statistics
http://www.fda.gov/cder/pediatric/exgrant.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)

Efficacy Supplement Approvals http://www.fda.gov/cder/rdmt/ESCY07AP.htm

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

Amlodipine Besylate Tablets, Wockhardt, Approval

Carvedilol Tablets, Glenmark Pharma, Approval

Carvedilol Tablets, Aurobindo Pharma, Approval

Carvedilol Tablets, Lupin, Approval

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma,
Labeling Revision

Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling
Revision

Omniscan (gadodiamide) Injection, GE Healthcare, Approval

Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval

Topiramate Capsules, Mylan Pharma, Tentative Approval

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

September 6, 2007

FDA approves the first generic versions of Coreg (carvedilol). FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html

FDA approves Somatuline Depot (lanreotide acetate injection) for the
treatment of acromegaly. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html

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

Amlodipine Besylate Tablets, Actavis, Approval

Carvedilol Tablets, Actavis Elizabeth, Approval

Carvedilol Tablets, Apotex Corp., Approval

Carvedilol Tablets, Caraco Pharma, Approval

Carvedilol Tablets, Dr. Reddy's Labs, Approval

Carvedilol Tablets, Mylan Pharma, Approval

Carvedilol Tablets, Ranbaxy, Approval

Carvedilol Tablets, Sandoz Inc., Approval

Carvedilol Tablets, Taro Pharma, Approval

Carvedilol Tablets, Teva Pharma, Approval

Carvedilol Tablets, Watson Labs, Approval

Carvedilol Tablets, Zydus Pharma, Approval

Ciclopirox Topical Solution, Watson Labs, Tentative Approval

Clarithromycin Oral Suspension, Sandoz Inc., Approval

Differin (adapalene) Gel, Galderma Labs, Manufacturing Change or
Addition

Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets,
Takeda Global, Package Change

Hydrochlorothiazide Tablets, Cadista Pharma, Approval

MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE
HealthCare, Labeling Revision

Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120
mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin
dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Ofloxacin Otic Solution, Alcon, Tentative Approval

Omniscan Injection, GE HealthCare, Labeling Revision

September 5, 2007

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

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

Magnevist (gadopentetate dimeglumine) Injection, Bayer HealthCare,
Labeling Revision

Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth, Tentative
Approval

MultiHance (gadobenate dimeglumine) Injection, Bracco Diagnostics,
Labeling Revision

MultiHance (gadobenate dimeglumine) Multipack Injection, Bracco
Diagnostics, Labeling Revision

Nystatin /Triamcinolone Acetonide Cream, Taro Pharma, Facility Addition

OptiMARK (gadoversetamide) Injection, Mallinckrodt Inc., Labeling
Revision

ProHance (gadoteridol) Injection, Bracco Diagnostics, Labeling Revision

Proquin (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed
Inc., Labeling Revision

Voltaren (diclofenac sodium) Ophthalmic Solution, Novartis Pharma,
Labeling Revision

September 4, 2007

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

Ranitidine Hydrochloride Tablets, Dr. Reddy's Labs, Approval

Trileptal (oxcarbazepine) Oral Solution, Novartis Pharma, Labeling
Revision

Trileptal (oxcarbazepine) Tablets, Novartis Pharma, Labeling Revision

Ultravist (brand of iopromide) Injection, Bayer HealthCare Pharma,
Labeling Revision

Pediatric Research Equity Act (PREA) Labeling Changes
http://www.fda.gov/cder/pediatric/Prea_label_post-mar_2_mtg.htm
(updated)

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posted by Mags @ 5:48 PM, ,

CDERNEW-TEXT 9/7/2007

September 7, 2007

BPCA/Pediatric Exclusivity Statistics:

Pediatric Exclusivity Statistics
http://www.fda.gov/cder/pediatric/exgrant.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)

Efficacy Supplement Approvals http://www.fda.gov/cder/rdmt/ESCY07AP.htm

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

Amlodipine Besylate Tablets, Wockhardt, Approval

Carvedilol Tablets, Glenmark Pharma, Approval

Carvedilol Tablets, Aurobindo Pharma, Approval

Carvedilol Tablets, Lupin, Approval

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma,
Labeling Revision

Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling
Revision

Omniscan (gadodiamide) Injection, GE Healthcare, Approval

Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval

Topiramate Capsules, Mylan Pharma, Tentative Approval

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

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posted by Mags @ 5:41 PM, ,

CDERNEW-TEXT 9/6/2007

Thursday, September 6, 2007

September 6, 2007

FDA approves the first generic versions of Coreg (carvedilol). FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html

FDA approves Somatuline Depot (lanreotide acetate injection) for the
treatment of acromegaly. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html

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

Amlodipine Besylate Tablets, Actavis, Approval

Carvedilol Tablets, Actavis Elizabeth, Approval

Carvedilol Tablets, Apotex Corp., Approval

Carvedilol Tablets, Caraco Pharma, Approval

Carvedilol Tablets, Dr. Reddy's Labs, Approval

Carvedilol Tablets, Mylan Pharma, Approval

Carvedilol Tablets, Ranbaxy, Approval

Carvedilol Tablets, Sandoz Inc., Approval

Carvedilol Tablets, Taro Pharma, Approval

Carvedilol Tablets, Teva Pharma, Approval

Carvedilol Tablets, Watson Labs, Approval

Carvedilol Tablets, Zydus Pharma, Approval

Ciclopirox Topical Solution, Watson Labs, Tentative Approval

Clarithromycin Oral Suspension, Sandoz Inc., Approval

Differin (adapalene) Gel, Galderma Labs, Manufacturing Change or
Addition

Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets,
Takeda Global, Package Change

Hydrochlorothiazide Tablets, Cadista Pharma, Approval

MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE
HealthCare, Labeling Revision

Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120
mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin
dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Ofloxacin Otic Solution, Alcon, Tentative Approval

Omniscan Injection, GE HealthCare, Labeling Revision

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posted by Mags @ 3:55 PM, ,

CDERNEW-TEXT 9/5/2007