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March 12, 2008
- New and Generic Drug Approvals
- Clobetasol Propionate Foam, Perrigo, Approval
- Levoleucovorin Injection, Spectrum Pharms, Approval
- Prozac (fluoxetine HCl) Capsules, Eli Lilly and Co., Labeling Revision
- Prozac (fluoxetine HCl) Oral Solution, Eli Lilly and Co., Labeling Revision
- Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly and Co., Labeling Revision
- Rosiglitazone Maleate Tablets, Roxane Labs, Tentative Approval
- BPCA/Pediatric Exclusivity Statistics:
- Written Requests Issued (updated)
- Written Requests Statistics (updated)
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML]
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Office of Generic Drugs: February First-Time Generic Drug Approvals
- Paragraph IV Patent Certifications (updated)
March 11, 2008
- FDA updates screening method for heparin: Impurity Evaluation of Heparin Sodium by 1H-NMR Spectroscopy
- FDA issues an Information for Healthcare Professionals sheet and Public Health Advisory for Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. Drug Information
- FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information
Update : 2
Subject: Enforcement Report for March 12, 2008
Enforcement Report for March 12, 2008
Tue, 13 Mar 2007 07:08:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update : 3
Subject: Oncology Drugs Update: New Approval for Bevacizumab (Avastin)
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On February 22, 2008, the U.S. Food and Drug Administration granted accelerated approval for bevacizumab (Avastin, Genentech, Inc.) to be used in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. More information at http://www.fda.gov/cder/Offices/OODP/whatsnew/bevacizumab200802.htm
Update : 4
Subject: Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension. Overview Version.
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Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension. Overview Version.
Thu, 13 Mar 2008 16:00:00 -0500
Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old. Overview Version.
Update : 5
Subject: Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension. Full Version.
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Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension. Full Version.
Thu, 13 Mar 2008 16:00:00 -0500
Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old. Full Version.
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