• Guidance for Industry: Individual Product Bioequivalence Recommendations [HTML] has been revised with Finalized recommendations.
• CDER Organization Charts [HTML] [PDF] (updated)
• List of Authorized Generic Drugs

June 26, 2008

• New and Generic Drug Approvals
  • Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision
  • Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., New or Modified Indication
  • Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
  • Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
  • Azithromycin Oral Suspension, Teva Pharmaceuticals USA, Approval
  • Celestone Soluspan (betamethasone acetate and betamethasone sodium phosphate) Injection, Schering Corp., Labeling Revision
  • Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics, Inc., Approval
  • Famotidine Injection, Akorn-Strides, LLC, Approval
  • PrandiMet (repaglinide and metformin hydrochloride) Tablets, Novo Nordisk, Inc., Approval
  • Viramune (nevirapine) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Patient Population Altered
  • Viramune (nevirapine) Tablet, Boehringer Ingelheim Pharmaceuticals, Inc., Patient Population Altered

June 25, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Patient Population Altered
  • KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
  • Spiriva Inhalation Powder, Boehringer Ingelheim, Labeling Revision

June 24, 2008

• FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) 2008. August 4, 2008, Chicago, Illinois. Meeting information and registration
• New and Generic Drug Approvals
  • Cetirizine Hydrochloride Syrup, Taro Pharmaceutical Industries, Ltd., Approval
  • Doryx (doxycycline hyclate) Delayed-Release Tablets, Warner Chilcott (U.S.), Inc., Formulation Revision
  • Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics, Inc., Approval
  • Kuvan (sapropterin dihydrochloride) Tablets, BioMarin Pharmaceuticals, Inc., Package Change
  • Micronor (norethindrone) Tablets, Ortho McNeil Pharmaceutical, Inc., Labeling Revision
  • Ramipril Capsules, Dr. Reddy's Labs, Ltd., Approval
  • Ramipril Capsules, Apotex Corp., Approval
  • Rowasa (mesalamine) Enema, Alaven Pharmaceutical, LLC, Formulation Revision
  • Valganciclovir Hydrochloride Tablets, Ranbaxy, Inc., Tentative Approval
  • Velcade (bortezomib) Intravenous Injection, Millennium Pharmaceuticals, Inc., New or Modified Indication
  • Zaleplon Capsules, Cipla, Ltd., Approval
  • Zyvox (linezolid) Tablets, Pharmacia & Upjohn, Labeling Revision
  • Zyvox (linezolid) IV Injection, Pharmacia & Upjohn, Labeling Revision
  • Zyvox (linezolid) Oral Suspension, Pharmacia & Upjohn, Labeling Revision

June 23, 2008

• Paragraph IV Patent Certifications (updated)

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June 27, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies. Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations.   June 26, 2008 Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Brief Summary Federal Register: Hematology and Pathology Devices Panel for the Medical Devices Advisory Committee; Notice of Meeting.   June 24, 2008 Federal Register: Medical Devices; Change of Name; Technical Amendment.   June 23, 2008 PMA Final Decisions for May 2008

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