• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• New and Generic Drug Approvals
  • Colistimethate Injection, AAP Pharma, Approval
  • Crixivan (indinavir sulfate) Capsules, Merck & Co., Labeling Revision
  • Diclofenac Sodium Ophthalmic Solution, Akorn Inc., Approval
  • Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharma, Approval
  • Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin (levofloxacin) Injection, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
  • Lithium Carbonate Capsules, West-Ward Pharma, Approval
  • Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Approval
  • Pilopine HS (pilocarpine hydrochloride) Ophthalmic Gel, Alcon Research, Labeling Revision
  • Pipracil (piperacillin sodium) Injection, Wyeth Pharma, Labeling Revision
  • Raloxifene Hydrochloride Tablets, Teva Pharma, Tentative Approval
  • Rizatriptan Benzoate Tablets, Teva Pharma, Tentative Approval
  • Sumatriptan Succinate Injection, Wockhardt, Approval
  • Treximet (sumatriptan, naproxen sodium) Tablets, Prozen Inc., Approval
• Office of Generic Drugs: March First-Time Generic Drug Approvals

April 17, 2008

• Postmarketing Study Commitments: Introduction (updated)

April 16, 2008

• CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg"
• Drugs@FDA Downloadable Data Files (updated)
• Inactive Ingredient Search for Approved Drug Products
• New and Generic Drug Approvals
  • Advicor (niacin lovastatin) Extended Release Tablets, Abbott Labs, Labeling Revision
  • Diprivan (propofol) Injection, APP Pharma, Labeling Revision
  • Nallpen in Plastic Container (nafcillin sodium) Injection, Baxter Healthcare, Labeling Revision
  • Ofloxacin Ophthalmic Solution, Akorn Inc., Approval 
  • TriCor (fenofibrate) Tablets, Abbott Labs, Labeling Revision

April 15, 2008

• New and Generic Drug Approvals
  • Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Labeling Revision
  • Cleocin Phosphate in Dextrose 5% in Plastic Container (clindamycin phosphate) I.V. Sterile Solution, Pfizer, Labeling Revision
  • Evamist (estradiol) Transdermal Spray, KV Pharma, Labeling Revision
  • Luvox (fluvoxamine maleate) Tablets, Jazz Pharma, Approval
  • PULMICORT FLEXHALER (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
  • Trelstar Depot (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
  • Trelstar LA (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
  • Unasyn (ampicillin sodium, sulbactam sodium) Injection, Pfizer, Labeling Revision
  • Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Control Supplement
  • Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Labeling Revision
• Paragraph IV Patent Certifications (updated)

April 14, 2008

• Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL) (updated)

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April 18, 2008 Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs   April 17, 2008 Consumer Information on: Talent Abdominal Stent Graft System - P070027   April 15, 2008 PMA Final Decisions for March 2008

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