CDERNEW-TEXT 10/11/2007
Thursday, October 11, 2007
October 11, 2007
Guidance for Industry: Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed without an Approved
Application [PDF http://www.fda.gov/cder/guidance/7950dft.pdf ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension,
Bristol-Myers Squibb, Labeling Revision
Omnipred (prednisolone acetate) Ophthalmic Suspension, Alcon Labs,
Labeling Revision
Oxcarbazepine Tablets, Glenmark Pharma, Approval
Oxcarbazepine Tablets, Sun Pharma, Approval
Oxcarbazepine Tablets, Roxane Labs, Approval
Simvastatin Orally Disintegrating Tablets, Synthon Pharma, Approval
Velcade (bortezomib) Injection, Millennium Pharma, Efficacy Supp.
w/Clinical Data
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posted by Mags @ 5:23 PM,
