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Center for Drug Evaluation &
Research (CDER) News

• Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland. Public Workshop Information (updated)
• New and Generic Drug Approvals
  • Aczone (dapsone) Gel, Allergan, Inc., Manufacturing Change or Addition
  • Niaspan (niacin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
  • Novothyrox (levothyroxine sodium) Tablets, Merck KGaA, Labeling Revision
  • Omnitrope (somatropin [rDNA origin]) Injection, Sandoz, Inc., Expiration Date Change
  • Ranexa (ranolazine) Extended-Release Tablets, CV Therapeutics, Manufacturing Change or Addition
• Office of Generic Drugs: List of Authorized Generic Drugs (updated)

March 26, 2009

• CDER Manual of Policies and Procedures (MaPP) 4151.7R Joint Safety Meetings Between OND and OSE
• New and Generic Drug Approvals
  • Azithromycin Injection, Sagent Strides LLC., Approval
  • CaloMist (cyanocobalamin) Nasal Spray, Fleming & Co., Pharmaceuticals, Package Change
  • Visicol (sodium phosphate, monobasic, monohydrate, sodium phosphate and dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
  • OsmoPrep (sodium phosphate, monobasic, monohydrate, sodium phosphate and dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
• Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009

March 25, 2009

• Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland. Public Workshop Information (updated)
• Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
• New and Generic Drug Approvals
  • Azelastine Hydrochloride Ophthalmic Solution, Apotex Inc., Tentative Approval
  • Bupropion Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Approval
  • Flumazenil Injection, Hikma Farmaceutica (Portugal) S.A., Approval
  • Ibuprofen Capsules, Banner Pharmacaps Inc.,  Approval
  • Risperidone Tablets, Cadista Pharmaceuticals Inc., Approval
  • Sulfacetamide Sodium Lotion, Perrigo Company of Tennessee, Inc., Approval

March 24, 2009

• Office of Generic Drugs:
  • February First-Time Generic Drug Approvals
  • Generic Drug Petition Tracking: Suitability Tracking Reports (updated)
• New and Generic Drug Approvals
  • Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics,  Labeling Revision
  • Levetiracetam Tablets, Cipla Ltd., Approval
  • Taclonex Scalp (betamethasone dipropionate and calcipotriene hydrate) Topical Suspension, Warner Chilcott (US), LLC, Package Change
  • Tygacil (tigecycline) I.V. Injection, Wyeth Pharmaceuticals, Inc., New or Modified Indication

March 23, 2009

• FDA Regulatory Process and Standards for Review and Approval of Opioid Analgesics; An Educational Primer and Conversation, February 10, 2009, Information and Presentations
• Drug Shortages: Current Drug Shortage: Cisplatin Injection 1mg/ml (updated)
• Drug Shortages: Current Drug Shortage: Leucovorin Calcium Solution for Injection (updated)
• New and Generic Drug Approvals
  • Levalbuterol Inhalation Solution, Dey LP, Approval
  • Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Patient Population Altered
  • Lexapro (escitalopram oxalate) Oral solution, Forest Laboratories, Inc., Patient Population Altered
  • Liothyronine Sodium Tablets, Coastal Pharmaceuticals, Approval
  • Risperidone Oral Solution, Dr. Reddy's Laboratories Ltd., Tentative Approval
  • Stavudine Oral Solution, Cipla Ltd., Approval

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