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Center for Drug Evaluation &
Research (CDER) News

• New and Generic Drug Approvals
  • Augmentin '125' (amoxicillin and clavulanate potassium), Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '125' (amoxicillin and clavulanate potassium), Oral Suspension Powder, GlaxoSmithKline, Labeling Revision
  • Augmentin '200' (amoxicillin and clavulanate potassium), Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '200' (amoxicillin and clavulanate potassium), Oral Suspension Powder, GlaxoSmithKline, Labeling Revision
  • Augmentin '250' (amoxicillin and clavulanate potassium), Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '250' (amoxicillin and clavulanate potassium), Oral Suspension Powder, GlaxoSmithKline, Labeling Revision
  • Augmentin '250' (amoxicillin and clavulanate potassium), Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '400' (amoxicillin and clavulanate potassium), Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '400' (amoxicillin and clavulanate potassium), Oral Suspension Powder, GlaxoSmithKline, Labeling Revision
  • Augmentin '500' (amoxicillin and clavulanate potassium), Tablets, GlaxoSmithKline, Labeling Revision
  • Augmentin '875' (amoxicillin and clavulanate potassium), Tablets, GlaxoSmithKline, Labeling Revision
     
  • Clobetasol Propionate, Lotion, Actavis Mid Atlantic, LLC, Approval
  • Dorzolamide Hydrochloride, Ophthalmic Solution, TEVA Parenteral Medicines, Inc., Approval

December 4, 2008

• Division of Drug Marketing, Advertising, and Communications Letter: AstraZeneca, Seroquel (quetiapine fumarate)
• Drugs Shortages: Resolved Drug Shortages; MVI Adult Injectable
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• National Drug Code Directory
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• New and Generic Drug Approvals
  • Acular LS (ketorolac tromethamine) Ophthalmic Solution, Allergan, Inc., Labeling Revision
  • Avandamet (rosiglitazone maleate and metformin HCl), Tablets, SB Pharmco Puerto Rico, Inc, Labeling Revision
  • Avandaryl (rosiglitazone maleate and glimepiride), Tablets, SB Pharmco Puerto Rico, Inc, Labeling Revision
  • Butalbital, Acetaminophen and Caffeine Tablets, Tablet, Concord Laboratories, Inc., Approval
  • Children’s Advil Cold (ibuprofen and pseudoephedrine hydrochloride), Wyeth Consumer Healthcare, Labeling Revision
  • Demeclocycline Hydrochloride, Tablets, Covenant Pharma, Inc., Approval
  • Escitalopram Oxalate, Oral Solution, Aurobindo Pharma USA, Inc., Tentative Approval
  • Flomax (tamsulosin hydrochloride), Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Miralax (polyethylene glycol 3350), Oral Solution, Schering-Plough HealthCare Products, Package Change
  • Perindopril Erbumine, Tablets, Aurobindo Pharma USA, Inc., Tentative Approval
  • Perindopril Erbumine, Tablets, IVAX Pharmaceuticals, Inc., Tentative Approval
  • Prilosec (omeprazole magnesium), Delayed-Release Oral Capsules, Astra Zeneca, Labeling Revision
  • Prilosec (omeprazole), Delayed-Release Capsules, Astra Zeneca, Labeling Revision
  • Rosiglitazone Maleate, Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
  • Sodium Polystyrene Sulfonate, Oral or Rectal Powder, Novel Laboratories, Inc., Approval
  • Tigan (trimethobenzamide hydrochloride), Capsules, King Pharmaceuticals, Inc., Labeling Revision

December 3, 2008

• Drugs Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Boniva (ibandronate sodium) Tablets, Hoffman-La Roche, Inc., New or Modified Indication
  • Levemir (insulin detemir [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • MDP-Bracco (technetium tc 99m medronate kit) Injection, Bracco Diagnostics, Inc., Manufacturing Change or Addition
  • NovoLog (insulin aspart [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • Pamidronate Disodium Injection, Cipla Limited, Approval
  • Rocuronium Bromide Injection, GeneraMedix Inc., Approval
  • Rocuronium Bromide Injection, Hospira, Inc., Approval
  • Rocuronium Bromide Injection, Teva Parenteral Medicines, Inc., Approval
  • Synthetic Conjugated Estrogens, Vaginal Cream, Duramed Research, Inc, Approval

December 2, 2008

• FDA issues questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs).
• Innohep (tinzaparin): Clinical study stopped early because of interim finding of increased all-cause mortality in patients who received drug. Information

December 1, 2008

• FDA Data Standards Manual (updated)
• New and Generic Drug Approvals
  • Boniva (ibandronate sodium) Tablets, Hoffman-La Roche, Inc., New or Modified Indication
  • Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Control Supplement, Labeling 
  • Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Control Supplement, Labeling
  • Bupropion Hydrochloride Extended-Release Tablets, IMPAX Laboratories, Inc., Control Supplement, Labeling
  • Irinotecan Hydrochloride Injection, Teva Parenteral Medicines, Inc., Approval
  • Levemir (insulin detemir [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • MDP-Bracco (technetium tc 99m medronate kit ) Injection, Bracco Diagnostics, Inc., Manufacturing Change or Addition
  • NovoLog (insulin aspart [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • NovoLog Mix 70/30 (insulin aspart protamine [rDNA origin] and insulin aspart [rDNA origin]) Subcutaneous Injection, NovoNordisk Inc., Labeling Revision
  • Phenergan w/Codeine (codeine phosphate and promethazine hydrochloride) Syrup, , ANI Pharmaceuticals, Inc., Labeling Revision
  • Risperidone Oral Solution, Apotex Inc., Tentative Approval
  • Rocuronium Bromide Injection, GeneraMedix Inc., Approval
  • Rocuronium Bromide Injection, Teva Parenteral Medicines, Inc., Approval
  • Rocuronium Bromide Injection, Hospira, Inc., Approval
  • Synthetic Conjugated Estrogens Vaginal Cream, Duramed Research, Inc., Approval
• Paragraph IV Patent Certifications (updated)

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December 5, 2008 510(k) Final Decisions - November 2008 Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, December 9, 2008 - Agenda, Roster, Briefing, Questions Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage   December 4, 2008 Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Agenda, Roster, Briefing, Questions

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