• Current Drug Shortage: Tikosyn (0.5mg and 0.25mg capsules)
• New and Generic Drug Approvals
  • Amlodipine Besylate Tablets, Interpharm Inc., Approval
  • Anthelios 20 (ecamsule, avobenzone, octocrylene, titanium dioxide) cream, L’Oreal Products, Labeling Revision 
  • Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision 
  • Ciprofloxacin Ophthalmic Solution, PharmaForce, Inc., Approval
  • Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharma, Approval
  • Fluoxetine Capsules, Wockhardt Inc., Approval
  • Fluticasone Propionate Nasal Spray, Hi-Tech Pharmacal, Approval
  • Nimodipine Capsules, Banner Pharmacaps, Approval
  • Omnitrope (somatropin [rDNA origin]) Injection, Sandoz Inc., Formulation Revision
  • Tamiflu (oseltamivir phosphate) Capsules, Hoffman-La Roche, Labeling Revision
  • Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman-La Roche, Labeling Revision

January 17, 2008

• FDA issues a Public Health Advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years. FDA News | Public Health Advisory
   
• Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment [PDF]

January 16, 2008

• BPCA/Pediatric Exclusivity Statistics:
  • Breakdown of Requested Studies Report (updated)
  • Pediatric Exclusivity Labeling Changes (updated)
  • Spectrum of Diseases/Conditions (updated)
  • Written Requests Issued (updated)
  • Written Requests Statistics (updated)
• Dissolution Methods Database (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA issues a Federal Register notice [HTML] [PDF] to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence.
• FDA issues a Public Health Advisory on edetate disodium (marketed as Endrate and generic products)
• New and Generic Drug Approvals
  • Alvesco (ciclesonide) Inhalation Aerosol, Nycomed, Approval 
  • Byetta (exenatide) Injection, Amylin Pharma, Labeling Revision
  • Ceftriaxone for Injection, Luitpold Pharma, Approval
  • CELEBREX (Celecoxib) Capsules, G.D. Searle, Labeling Revision
  • Cetirizine Hydrochloride Chewable Tablets, Caraco Pharma, Approval
  • Clopidogrel Tablets, Dr. Reddy’s Labs, Approval 
  • Donepezil Hydrochloride Tablets, Teva Pharma, Tentative Approval 
  • Donepezil Hydrochloride Tablets, Roxane Labs, Tentative Approval 
  • Glipizide and Metformin Hydrochloride Tablets, Caraco Pharma, Approval
  • Granisetron Hydrochloride Injection, Apotex, Tentative Approval
  • Ketorolac Tromethamine Injection, Luitpold Pharma, Approval
  • Oxcarbazepine Tablets, Breckenridge Pharma, Approval
  • Polymyxin B for Injection, Abraxis Pharma, Approval
  • Pravastatin Sodium Tablets, Teva Pharma, Approval
  • Rapamune (Sirolimus) Oral Solution, Wyeth Pharma, Efficacy Supp. w/Clinical Data
  • Rapamune (Sirolimus) Tablets, Wyeth Pharma, Efficacy Supp. w/Clinical Data
  • Triglide (fenofibrate) Tablets, Sciele Pharma, Labeling Revision

January 15, 2008

• Cyber Warning Letters (updated)
• FDA approves Tysabri (natalizumab) to treat moderate-to-severe Crohn's Disease.
• Inactive Ingredients for Approved Drug Products (Search)
• Inactive Ingredients for Approved Drug Products (Download)
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

January 14, 2008

• New and Generic Drug Approvals
  • FEMCON Fe (norethindrone and ethinyl estradiol) Tablets, Warner Chilcott, Labeling Revision
  • Fentanyl Transdermal System, Lavipharm Labs, Control Supplement 
  • Fluconazole Tablets USP, Taro Pharma, Control Supplement
  • Hydrocodone Bitartrate and Acetaminophen Tablets, Watson Labs, Supplier Addition
  • OPANA ER (oxymorphone HCl) Extended-Release Tablets, Endo Pharma, Control Supplement
  • Propranolol Hydrochloride Tablets, Northstar, Approval
• Office of Generic Drugs:
  • Paragraph IV Patent Certifications (updated)
  • December First-Time Generic Drug Approvals
  • Suitability Petitions (updated)

CDER Drug Links

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Biological Product Shortages - Yellow Fever Vaccine
Posted: 1/18/2008

Approval Information: Thrombin, topical (Recombinant) (RECOTHROM)
Posted: 1/17/2008, Approval Date: 1/17/2008

FDA Approves First Clotting Solution Made Using Recombinant DNA Technology
Posted: 1/17/2008

American Course on Drug Development and Regulatory Sciences - Slide Presentation
Posted: 1/17/2008

Approval Information: Human T-Lymphotropic Virus Types I and II (ABBOTT PRISM HTLV-I/HTLV-II)
Posted: 1/17/2008, Approval Date: 1/16/2008

Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices; Proposed Rule
Posted: 1/16/2008

FDA Approves Sealant to Control Bleeding During Surgery
Posted: 1/16/2008

Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Updated labeling
Posted: 1/14/2008, Approval Date: 1/9/200

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January 17, 2008
	Circulatory System Devices Panel Advisory Meeting, November 29-30, 2007 - Slides
January 16, 2008
	Medical Device Safety, Tips & Articles: Waking up to hospital bed entrapment risks
January 15, 2008
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3601A.
	FDA Public Health Notification: Unretrieved Device Fragments
January 14, 2008
	Japan - U.S. "Harmonization By Doing" HBD Pilot Program Initiative - Updated January 2008

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