News - Drug Approvals - Meetings

June 26, 2009

• Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
• BPCA of 2007: List of Determinations including Written Request
• Drug Safety Oversight Board Meeting, Public Summary, May 21, 2009
• FDA Drug Safety Newsletter - Volume 2, Number 2, 2009

June 25, 2009

• Drugs@FDA Download File (updated)
• Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland
• U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
• Facts About Current Good Manufacturing Practices (cGMPs)

June 24, 2009

• Drug Shortages: Drugs to be Discontinued: Nandrolone Decanoate Injection

June 23, 2009

• DDMAC Letter: Velcade(bortezomib) for injection
• First-Time Generic Drug Approvals in May 2009

• Alclometasone Dipropionate Topical Cream, Glenmark Generics, Ltd., Approval
• Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision
• Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Labeling Revision
• Entocort EC (budesonide) Capsules, AstraZeneca Pharmaceuticals, LP, Labeling Revision
• Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray, Upsher-Smith Laboratories, Inc., Labeling Revision
• Granisetron Hydrochloride Tablets, Natco Pharma, Ltd., Approval
• Granisetron Hydrochloride Injection, West-Ward Pharmaceutical Corp., Tentative Approval
• Metronidazole Capsules, Alembic, Ltd., Approval
• Progesterone Injection, PharmaForce, Inc., Approval
• Vancomycin Hydrochloride Injection, Akorn–Strides, LLC, Labeling

 June 24, 2009

• Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision
• CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision
• CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision
• CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision
• Galantamine Hydrobromide Tablets, Sandoz Inc., Approval
• Lamivudine Tablets, Matrix Laboratories Ltd., Tentative Approval
• Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, Efficacy Supp. w/Clinical Data
• Salonpas Patch (menthol and methyl salicylate) Patch, Pharmaceutical Development Group, Inc., Labeling Revision
• Sarafem (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision

June 23, 2009

• Cambia (diclofenac) Powder for Oral Solution, Kowa Pharmaceuticals America, Inc., Approval
• Chlorhexidine Gluconate Dental Solution, Xttrium Laboratories, Inc., Approval
• Ethambutol Hydrochloride Tablets, Lupin Ltd., Approval
• Lipitor (atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision
• Oxaliplatin Injection, Hospira Worldwide Pty, Tentative Approval
• Quinapril Hydrochloride Tablets, Sun Pharmaceutical Industries, Ltd., Approval
• Ozurdex (dexamethasone) Intravitreal Implant, Allergan, Inc., Approval
• Patanase Nasal Spray (olopatadine hydrochloride), Alcon Pharmaceuticals, Inc., Efficacy Supp w/Clinical Data
• Risperidone Tablets USP, Actavis Totowa LLC, Approval
• Vecuronium Bromide Injection, Sun Pharma Global Inc., Approval

• Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland
• Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit, June 10-12, 2009, Hilton Washington DC/Rockville 1750 Rockville Pike, Rockville, MD. Meeting Information
• 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration
• Quality Risk Management – Implementation Strategies; US FDA/CDER and University of Rhode Island College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency Bethesda, Bethesda, Maryland. Meeting Information.
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, MD.