Date: February 14 - February 18, 2006 February 17, 2006 Orange Book Query Orange Book Current Cumulative Supplement Orange Book - Information and Data Files Orange Book Monthly Additions and Deletions Postmarketing Study Commitments: Introduction (updated) February 16, 2006 New and Generic Drug Approvals ACETADOTE (acetylcysteine) Injection, Cumberland Pharma, Labeling Revision Adenosine Injection, Sicor Pharma, Tentative Approval Betoptic (betaxolol HCl ophthalmic solution), Alcon Labs, Labeling Revision Cefoxitin Injection, Orchid Healthcare, Approval Donepezil Hydrochloride Tablets, Par Pharmaceutical, Tentative Approval Fosphenytoin Sodium Injection, Bedford Labs, Tentative Approval Nitrolingual (glyceryl trinitrate) Pumpspray, First Horizon Pharma, Labeling Revision Omeprazole Delayed Release Capsules, Dr. Reddy's Labs, Tentative Approval Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Vintage Pharma, Approval Rabeprazole Sodium Delayed Release Tablets, Teva Pharmaceuticals, Tentative Approval February 15, 2006 Patient Information Sheets Vaprisol (conivaptan) Orencia (abatacept) Drugs@FDA Downloadable Data Files (updated) Guidance Document: Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML] or [Word] or [PDF] Questions and Answers on Tysabri Regarding the Clinical Hold February 14, 2006 Guidance for Industry:  Nonclinical Safety Evaluation of Pediatric Drug Products [HTML] or [Word] or [PDF] February 13, 2006 Active Pharmaceutical Ingredient (API) Process Inspection; Compliance Program Guidance Manual BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Statistics (updated) Written Requests Issued (updated) Spanish version of "My Medicines" ("Mis Medicinas") guide posted on Consumer Education/Information page. Spanish version of  "Exceeding the Recommended Dosage Can Do More than Wipe Out Your Pain.  Just Ask Your Major Organs." ("Exceder La Dosis Recomendada Puede Eliminar Más Que El Dolor Que Usted Padece. Sólo Pregúntele A Sus Órganos Principales.") Public Service Announcement  posted on Consumer Education/Information page. We welcome any feedback or suggestions. webmaster@cder.fda.gov. If you prefer to subscribe to the previous text-only version, please send us a message.   ---------------------------------------------To subscribe or to unsubscribe from CDERWEEKwww.fda.gov/cder/cdernew/listserv.html --------------------------------------------- CDER Home PageContact CDER | FDA Home Page | HHS Home Page U.S. Food and Drug Administration Center for Drug Evaluation and Research 1-888-INFO-FDA (1-888-463-6332)

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