3 - 5 day on-site GLP, GMP, GCP, Systems, Part 11, FDA Mock 'Due Diligence' and Validation Audits starting at $4,995.00

• Drug Shortage; Current; A-methapred (methylprednisolone sodium succinate) for injection 125mg and 40mg
• Drug Shortage; Current; MVI Adult Injectable (updated)
• FDA approves Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. FDA News
• New and Generic Drug Approvals
  • Allopurinol Tablets, Northstar Healthcare, Approval
  • Fentanyl Transdermal System, Watson Labs, Approval
  • Fluconazole Oral Suspension, Ivax Pharma, Approval 
  • Fluticasone Propionate Nasal Spray, Apotex, Approval 
  • FML (fluorometholone) Ophthalmic Ointment, Allergan, Inc., Package Change
  • Keppra (levetiracetam) Injection, UCB Inc., Labeling Revision
  • Keppra (levetiracetam) Tablets, UCB Inc., Labeling Revision
  • Keppra (levetiracetam) Oral Solution, UCB Inc., Labeling Revision
  • Metoprolol Tartrate Tablets, Aurobindo Pharma, Approval

September 13, 2007

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• Fentora (fentanyl buccal tablet) - Cephalon issues two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora.
• New and Generic Drug Approvals
  • Amlodipine Besylate Tablets, Lek Pharma, Approval
  • Cefazolin Injection, USP and Dextrose Injection, USP in the Duplex Container, B. Braun Medical, Labeling Revision
  • Cefuroxime Injection and Dextrose Injection in the Duplex Container, B. Braun Medical, Labeling Revision
  • Colgate Total (sodium fluoride and triclosan dentifrice) Toothpaste, Colgate-Palmolive, Formulation Revision
  • Griseofulvin Oral Suspension, Ivax Pharma, Approval
  • Humulin R (insulin [rDNA origin]) Human Injection, Eli Lilly, Labeling Revision
  • Ibuprofen Tablets, Northstar Healthcare, Approval
  • Lamotrigine Tablets, Dr. Reddy’s Labs, Tentative Approval
  • Lamotrigine Chewable Tablets, Dr. Reddy’s Labs, Tentative Approval
  • Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Patient Population Altered
  • Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in dextrose) Injection, Ortho-McNeil Pharma, Patient Population Altered
  • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Patient Population Altered
  • Motrin (ibuprofen) Tablets, McNeil Pediatrics, Labeling Revision
  • Motrin (ibuprofen) Suspension, McNeil Pediatrics, Labeling Revision
  • Pantoprazole Sodium Delayed Release Tablet, Sun Pharma, Approval
  • Septra and Septra DS (trimethoprim/sulfamethoxazole) Tablets, Monarch Pharma, Labeling Revision

September 12, 2007

• Drugs@FDA Downloadable Data Files (updated)

September 11, 2007

• FDA issues an FDA Alert and Healthcare Professional sheet for Rocephin (ceftriaxone) clarifying concomitant use with calcium-containing products or solutions. Drug Information
• National Drug Code Directory Search
• National Drug Code Directory Download
• New and Generic Drug Approvals
  • Carvedilol Tablets, Hikma Pharma, Approval
  • Cefotaxime Injection and Dextrose Injection, B. Braun Medical, Inc., Labeling Revision 
  • Cromolyn Sodium Nasal Solution, QPharma, Approval
  • Tricor (fenofibrate) Tablets, Abbott Labs, Labeling Revision
  • Zolpidem Tartrate Tablets, Invagen Pharma, Approval

September 10, 2007

• CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A Changing Paradigm, October 15-16, 2007 Bethesda North Marriott Hotel & Conference Center. Meeting information
• New and Generic Drug Approvals
  • Actos (pioglitazone HCl) Tablets, Takeda Global Research, Labeling Revision
  • Alimta (pemetrexed) Injection, Eli Lilly & Co., Control Supplement
  • Humulin R (insulin human injection, USP [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humulin N NPH (human insulin isophane suspension [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humulin 50/50 (50% human insulin isophane suspension/50% insulin human injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change
  • Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change
  • Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision
  • Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change
  • RELENZA (zanamivir) Inhalation, GlaxoSmithKline, Labeling Revision
  • Sectral (acebutolol hydrochloride) Capsules, Dr. Reddy’s Labs, Labeling Revision
  • Topiramate Tablets, Aurobindo Pharma, Tentative Approval
  • Totect (dexrazoxane) Injection, TopoTarget Inc., Approval
• Pfizer issues a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate in Viracept (nelfinavir mesylate). MedWatch Safety Information