• Guidance for Industry: Bioequivalence Guidances: New additions for August 2008.
• New and Generic Drug Approvals
  • Bupropion Hydrochloride Extended-Release Tablets, Actavis South Atlantic, LLC, Approval
  • Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Dexamethasone Tablets, ECR Pharmaceuticals, Approval
  • FazaClo ODT (clozapine) Orally Disintegrating Tablets, Azur Pharmaceuticals International, Ltd., Labeling Revision
  • Hydrochlorothiazide Tablets, Unichem Laboratories Ltd., Approval
  • OptiMARK (gadoversetamide) Injection, Mallinckrodt, Inc., Labeling Revision
  • REYETAZ (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Labeling Revision
  • Sumatriptan Succinate Injection, Wockhardt Ltd., Tentative Approval 
  • Xenazine (tetrabenazine) Tablets, Prestwick Pharmaceuticals, Inc., Approval 
• Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration

August 21, 2008

• Drug Safety Oversight Board Meeting, July 17, 2008
• FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information
• Guidance for Industry: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF]
• New and Generic Drug Approvals
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
  • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
  • Abilify (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
  • Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
  • Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
  • Geodon (ziprasidone mesylate) Intramuscular Injection, Pfizer, Inc., Labeling Revision
  • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Navane (thiothixine) Capsules, Pfizer, Inc., Labeling Revision
  • Risperdal (risperidone) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Risperdal (risperidone) Orally Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Risperdal Consta (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
  • Symbyax (fluoxetine hydrochloride and olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
  • Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision
  • Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision
  • Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision
• USP Chapter <467> Residual Solvents - Additional Information

August 20, 2008

• PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, September 10-12, 2008, Washington, D.C. Meeting information and registration
• The Prescription Drug User Fee Act (PDUFA) News: The FY 2009 Product and Establishment Fee Invoices were mailed Friday, August 15, 2008. Full payment of the invoice is due by October 1, 2008. If you do not receive your invoice by August 25, 2008, please contact Michael Jones or Beverly Friedman at 301-796-3602.
• Generic Drug Petition Tracking: Suitability Tracking Reports (updated)

August 19, 2008

• Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
• New and Generic Drug Approvals
  • Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
  • Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
  • Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
  • Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
  • Haldol (haloperidol decanoate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Moban (molindone hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
  • Megace ES (megestrol acetate) Oral Suspension, Par Pharmaceutical, Inc., Labeling Revision
  • Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., Labeling Revision

August 18, 2008

• FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide).
• Paragraph IV Patent Certifications (updated)

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August 22, 2008 Federal Register: Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices   August 21, 2008 FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Online Registration Now Available) Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment Summary Information for: VIABAHN Endoprosthesis   August 20, 2008 Consumer Information on: T-SPOT.TB - P070006   August 18, 2008 Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Transcripts, Agenda, Minutes

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