CDERNEW-TEXT 11/1/2007
Thursday, November 1, 2007
November 1, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Adagen (pegademase bovine) Injection, Enzon Pharma, Labeling Revision
Bethanechol Chloride 5mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 10mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 25mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 50mg Tablets, Pharmax Group, Approval
DDAVP Intranasal (desmopressin acetate), Sanofi-Aventis, Labeling
Revision
DDAVP Injection (desmopressin acetate) , Sanofi-Aventis, Labeling
Revision
DDAVP Tablets (desmopressin acetate) , Sanofi-Aventis, Labeling Revision
Tri-Legest-21 (Norethindrone Acetate and Ethinyl Estradiol) Tablets,
Barr Labs, Approval
Visken (pindolol) Tablets, Novartis Pharma, Labeling Revision
VIVITROL (naltrexone) Extended-release Injectable Suspension, Alkermes
Inc., Labeling Revision
Warning Letter: Site Inspection - Northeast General Pharmaceutical
Factory http://www.fda.gov/cder/warn/warn2007.htm#October
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posted by Mags @ 5:01 PM,
